Micro-optic probes for neurology

ABSTRACT

An imaging system for a patient comprises an imaging probe. The imaging probe comprises: an elongate shaft for insertion into the patient and comprising a proximal end, a distal portion, and a lumen extending between the proximal end and the distal portion; a rotatable optical core comprising a proximal end and a distal end, the rotatable optical core configured to optically and mechanically connect with an interface unit; a probe connector positioned on the elongate shaft proximal end and surrounding at least a portion of the rotatable optical core and an optical assembly positioned in the elongate shaft distal portion and proximate the rotatable optical core distal end, the optical assembly configured to direct light to tissue and collect reflected light from the tissue. A shear-thinning fluid can be provided between the elongate shaft and the rotatable optical core, such as to reduce undesired rotational variations of the rotatable optical core.

RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 15/566,041 (Docket No. GTY-001-US), titled“Micro-Optic Probes for Neurology”, filed Oct. 12, 2017, United StatesPublication Number 2018-0125372, published May 10, 2018, which in aNational Phase entry of International PCT Patent Application SerialNumber PCT/US2016/027764 (Docket No. GTY-001-PCT), titled “Micro-OpticProbes for Neurology” filed Apr. 15, 2016, Publication Number WO2016/168605, published Oct. 20, 2016, which claims the benefit of: U.S.Patent Provisional Application Ser. No. 62/322,182, titled “Micro OpticProbes for Neurology”, filed Apr. 13, 2016 and U.S. ProvisionalApplication Ser. No. 62/148,355, titled “Micro-Optic Probes forNeurology”, filed Apr. 16, 2015, the content of each of which isincorporated herein by reference in its entirety for all purposes. Thisapplication is related to: U.S. Provisional Application Ser. No.62/212,173, titled “Imaging System includes Imaging Probe and DeliveryDevices”, filed Aug. 31, 2015; the content of which is incorporatedherein by reference in its entirety for all purposes.

FIELD

Inventive concepts relate generally to imaging systems, and inparticular, neural imaging systems including imaging probes, imagingconsoles and delivery devices.

BACKGROUND

Imaging probes have been commercialized for imaging various internallocations of a patient, such as an intravascular probe for imaging apatient's heart. Current imaging probes are limited in their ability toreach certain anatomical locations due to their size and rigidity.Current imaging probes are inserted over a guidewire, which cancompromise their placement and limit use of one or more deliverycatheters through which the imaging probe is inserted. There is a needfor imaging systems that include probes with reduced diameter, highflexibility and ability to be advanced to a patient site to be imagedwithout a guidewire, as well as systems with one or more deliverydevices compatible with these improved imaging probes.

SUMMARY

According to one aspect of the present inventive concepts, an imagingsystem for a patient comprises: an imaging probe and is configured toproduce an image of the patient. The imaging probe comprises: anelongate shaft for insertion into the patient and comprising a proximalend, a distal portion, and a lumen extending between the proximal endand the distal portion; a rotatable optical core comprising a proximalend and a distal end, the rotatable optical core configured to opticallyand mechanically connect with an interface unit; a probe connectorpositioned on the elongate shaft proximal end and surrounding at least aportion of the rotatable optical core; and an optical assemblypositioned in the elongate shaft distal portion and proximate therotatable optical core distal end, the optical assembly configured todirect light to tissue and collect reflected light from the tissue.

In some embodiments, the imaging probe comprises a shear-thinning fluidlocated within the distal portion of the elongate shaft, such as ashear-thinning fluid configured to reduce undesired rotational variancesof the rotatable optical core (e.g. and the attached optical assembly130) while avoiding excessive loads being placed on the rotatableoptical core.

In some embodiments, the imaging probe further comprises at least onespace reducing element positioned between the elongate shaft and therotatable optical core, and the at least one space reducing element canbe configured to reduce rotational speed variances of the rotatableoptical core. The at least one space reducing element can be positionedat least in a portion of the elongate shaft distal portion. The at leastone space reducing element can be configured to reduce the rotationalspeed variances by increasing the shear-thinning of the shear-thinningfluid.

In some embodiments, the imaging probe further comprises an inertialassembly configured to reduce rotational speed variances of therotatable optical core.

In some embodiments, the imaging probe further comprises an impellerattached to the rotatable optical core and configured to resist rotationof the rotatable optical core when the rotatable optical core isretracted.

In some embodiments, the imaging probe further comprises a stiffeningelement embedded into the elongate shaft that is configured to resistflexing of the elongate shaft and comprises an optically transparentportion.

In some embodiments, the imaging probe further comprises a reduced innerdiameter portion of the elongate shaft, wherein the reduced innerdiameter portion is configured to reduce rotational speed variances ofthe rotatable optical core.

In some embodiments, the imaging system is configured to create a threedimensional image by retraction of the elongate shaft.

In some embodiments, the imaging system is configured to detect and/orquantify malapposition of a flow diverter implanted in the patient.

In some embodiments, the imaging system is configured to providequantitative and/or qualitative information used to determine the sizeof a flow diverter to be implanted in the patient and/or position a flowdiverter in the patient. The quantitative and/or qualitative informationcan comprise information related to a parameter selected from the groupconsisting of: perforator location; perforator geometry; neck size; flowdiverter mesh density; and combinations thereof.

In some embodiments, the imaging system is configured to image a stentretriever at least partially positioned in thrombus of the patient. Theimaging system can be configured to image thrombus at least one of:thrombus not engaged with the stent retriever or thrombus not removed bythe stent retriever.

In some embodiments, the imaging system is configured to quantify avolume of thrombus in the patient. The quantified thrombus can comprisethrombus selected from the group consisting of: residual thrombus inacute stroke; thrombus remaining after a thrombus removal procedure;thrombus present after flow diverter implantation; and combinationsthereof.

In some embodiments, the imaging system is configured to provide implantsite information, and the implant site information is used to select aparticular implantable device for implantation in the patient. Thesystem can further comprise the implantable device for implantation inthe patient, and the implantable device can comprise a device selectedfrom the group consisting of: stent; flow diverter; and combinationsthereof. The implantable device can be selected based on an implantabledevice parameter selected from the group consisting of: porosity;length; diameter; and combinations thereof.

In some embodiments, the imaging system is configured to provideporosity information of a device implanted in the patient. The porosityinformation can comprise porosity of a portion of the implanted devicethat is to be positioned proximate a sidebranch of a vessel in which theimplanted device is positioned. The system can be configured to providethe porosity information based on a wire diameter of the implanteddevice. The system can further comprise the implanted device, and theimplanted device can comprise a device selected from the groupconsisting of: stent; flow diverter; and combinations thereof. Theimaging system can be further configured to provide information relatedto implanting a second device in the patient. The first implanted devicecan comprise a stent, and the second implanted device can comprise aflow diverter. The first implanted device can comprise a flow diverterand the second implanted device can comprise a flow diverter. Theimaging system can be further configured to provide an image duringdeployment of the implanted device. The imaging system can be furtherconfigured to allow modification of the implanted device while theoptical assembly is positioned proximate the implanted device. Themodification can comprise a modification of the porosity of theimplanted device. The system can further comprise a balloon catheterconfigured to perform the porosity modification.

In some embodiments, the imaging system is configured to image at leastone perforator artery of the patient. The at least one perforator arterycan comprise a diameter of at least 50 μm. The system can furthercomprise a therapeutic device. The therapeutic device can comprise adevice selected from the group consisting of: stent retriever;embolization coil; embolization coil delivery catheter; stent; coveredstent; stent delivery device; aneurysm treatment implant; aneurysmtreatment implant delivery device; flow diverter; balloon catheter; andcombinations thereof.

In some embodiments, the system further comprises at least one guidecatheter. The at least one guide catheter can comprise a microcatheter.The microcatheter can comprise an inner diameter between 0.0165″ and0.027″. The microcatheter can comprise an inner diameter between 0.021″and 0.027″.

In some embodiments, the imaging probe is constructed and arranged toaccess a vessel of a human being.

In some embodiments, the imaging probe is configured to access bloodvessels of the brain.

In some embodiments, the elongate shaft comprises a material selectedfrom the group consisting of: FEP; PTFE; Pebax; PEEK; Polyimide; Nylon;and combinations thereof.

In some embodiments, the elongate shaft comprises a material selectedfrom the group consisting of: stainless steel; nickel titanium alloy;and combinations thereof.

In some embodiments, the elongate shaft comprises a first portioncomprising a metal tube and a second portion comprising a braided shaft.

In some embodiments, the elongate shaft comprises a hydrophobic materialconfigured to reduce changes in length of the elongate shaft when theelongate shaft is exposed to a fluid.

In some embodiments, the elongate shaft comprises an outer diameter thatvaries along the length of the elongate shaft.

In some embodiments, the elongate shaft comprises an inner diameter thatvaries along the length of the elongate shaft.

In some embodiments, the elongate shaft comprises an outer diameterbetween 0.006″ and 0.022″.

In some embodiments, the elongate shaft comprises an outer diameter ofapproximately 0.0134″.

In some embodiments, the elongate shaft comprises an inner diameterbetween 0.004″ and 0.012″. The elongate shaft can comprise a wallthickness of approximately 0.003″.

In some embodiments, the elongate shaft comprises an outer diameter lessthan or equal to 500 μm.

In some embodiments, the elongate shaft comprises an outer diameter lessthan or equal to 1 mm.

In some embodiments, the elongate shaft comprises an outer diameter ofapproximately 0.016″. At least the most distal 30 cm of the elongateshaft can comprise an outer diameter less than or equal to 0.016″.

In some embodiments, the elongate shaft can comprise an outer diameterof approximately 0.014″. The elongate shaft can be configured to beadvanced through vasculature without a guidewire or delivery device. Atleast the most distal 30 cm of the elongate shaft can comprise an outerdiameter less than or equal to 0.014″.

In some embodiments, the elongate shaft comprises a mid portion proximalto the distal portion, and the distal portion comprises a larger outerdiameter than the mid portion. The elongate shaft distal portion cancomprise a larger inner diameter than the inner diameter of the midportion. The larger outer diameter distal portion can surround theoptical assembly.

In some embodiments, the elongate shaft comprises a length of at least100 cm. The elongate shaft can comprise a length of no more than 350 cm.

In some embodiments, the elongate shaft comprises a length of at least200 cm. The elongate shaft can comprise a length of at least 220 cm. Theelongate shaft can comprise a length of at least 240 cm. The elongateshaft can comprise a length of approximately 250 cm.

In some embodiments, the elongate shaft further comprises a middleportion, and the elongate shaft distal portion comprises a larger innerdiameter than the elongate shaft middle portion. The elongate shaftdistal portion inner diameter can be at least 0.002″ larger than theinner diameter of the elongate shaft middle portion. The elongate shaftdistal portion can comprise a similar outer diameter to the outerdiameter of the elongate shaft middle portion. The elongate shaft distalportion can comprise an outer diameter than is greater than the elongateshaft middle portion outer diameter. The elongate shaft distal portionouter diameter can be at least 0.001″ larger than the outer diameter ofthe elongate shaft middle portion. The elongate shaft distal portion cancomprise a wall thickness that is less than the elongate shaft middleportion wall thickness. The elongate shaft distal portion can comprise astiffer material than the elongate shaft middle portion. The elongateshaft distal portion can comprise a stiffening element.

In some embodiments, the elongate shaft distal portion comprises a rapidexchange guidewire lumen. The guidewire lumen can comprise a length ofless than or equal to 150 mm. The guidewire lumen can comprise a lengthof at least 15 mm. The guidewire lumen can comprise a length of at least25 mm.

In some embodiments, the elongate shaft distal portion comprises anoptically transparent window, and the optical assembly is positionedwithin the optically transparent window. The optically transparentwindow can comprise a length less than 20 mm, or less than 15 mm. Theoptically transparent window can comprise a material selected from thegroup consisting of: Pebax; Pebax 7233; PEEK; amorphous PEEK; polyimide;glass; sapphire; nylon 12; nylon 66; and combinations thereof. Theelongate shaft can comprise at least a first portion, positionedproximate the optically transparent window, and the first portion cancomprise a braided shaft. The elongate shaft can further comprise asecond portion positioned proximal to the first portion, and the secondportion can comprise a metal tube. The optically transparent window cancomprise a length between 1 mm and 100 mm. The optically transparentwindow can comprise a length of approximately 3 mm. The opticallytransparent window can comprise a material selected from the groupconsisting of: nylon; nylon 12; nylon 66; and combinations thereof.

In some embodiments, the elongate shaft comprises a stiffening element.The stiffening element can be positioned at least in the elongate shaftdistal portion. The stiffening element can be constructed and arrangedto resist rotation of the elongate shaft distal portion during rotationof the rotatable optical core. The stiffening element can terminateproximal to the optical assembly. The stiffening element can comprise acoil. The stiffening element can comprise metal coils wound over PTFE.The stiffening element can comprise a coil wound in a direction suchthat rotation of the rotatable optical core tightens the metal coil. Theimaging probe can further comprise a fluid positioned between therotatable optical core and the elongate shaft, and the metal coil can beconfigured to reduce twisting of the elongate shaft by torque forcesapplied by the fluid.

In some embodiments, the elongate shaft comprises a distal end, and theimaging probe comprises a spring tip attached to the elongate shaftdistal end. The spring tip can comprise a radiopaque portion. The springtip can comprise a length between 2 cm and 3 cm.

In some embodiments, the elongate shaft comprises a proximal portionconstructed and arranged to be positioned in a service loop, and theelongate shaft proximal portion has a different construction than theremainder of the elongate shaft. The different construction can comprisea larger outer diameter. The different construction can comprise athicker wall.

In some embodiments, the system further comprises a fluid positioned inthe elongate shaft lumen, and a fluid interacting element positioned inthe distal portion of the lumen of the elongate shaft, and the fluidinteracting element is configured to interact with the fluid to increaseload on the rotatable optical core during rotation of the rotatableoptical core. The fluid interacting element can comprise a coilpositioned in the elongate shaft lumen. The fluid interacting elementcan comprise a non-circular cross section of the lumen. The non-circularcross section can comprise a geometry selected from the group consistingof: polygon shaped cross section of a lumen of the elongate shaft;projections into a lumen of the elongate shaft; recesses in innerdiameter of the elongate shaft; and combinations thereof. The fluid cancomprise a low viscosity fluid. The fluid can comprise a viscosity at orbelow 1000 Cp.

In some embodiments, the imaging probe further comprises a first sealingelement located within the elongate shaft lumen, the sealing elementpositioned between the rotatable optical core and the elongate shaft,and configured to slidingly engage the rotatable optical core and toresist the flow of fluid around the sealing element (e.g. to provide aseal as the rotatable optical core is rotated). The first sealingelement can be positioned in the elongate shaft distal portion. Theimaging probe can further comprise a first liquid positioned proximatethe optical assembly and a second fluid positioned proximate therotatable optical core, and the first sealing element can be positionedbetween the first liquid and the second liquid. The first liquid cancomprise a first viscosity and the second liquid can comprise a secondviscosity greater than the first viscosity. The first sealing elementcan be further configured to resist rotation of the rotatable opticalcore. The first sealing element can comprise a hydrogel. The firstsealing element can comprise an adhesive bonded to the elongate shaft.The first sealing element can comprise a UV-cured adhesive bonded to theelongate shaft. The rotatable optical core can comprise a material thatdoes not bond to the adhesive. The first sealing element can comprise acompliant material. The compliant material can comprise silicone. Thesystem can further comprise a second sealing element positioned betweenthe rotatable optical core and the elongate shaft, and the secondsealing element can be configured to slidingly engage the rotatableoptical core and can be further configured to resist flow of fluidaround the second sealing element, and the imaging probe can furthercomprise a fluid positioned between the first sealing element and thesecond sealing element. The first and second sealing elements can beseparated by a distance of between 1 mm and 20 mm. The fluid positionedbetween the first and second sealing elements can comprise a viscositybetween 10 Cp and 100 Cp. The first sealing element can be positionedproximal and proximate the optical assembly and the second sealingelement can be positioned distal to the first sealing element.

In some embodiments, the imaging probe comprises a sealing elementpositioned proximate the proximal end of the elongate shaft. The sealingelement can be positioned between the elongate shaft and the probeconnector.

In some embodiments, the rotatable optical core comprises a single modeglass fiber with an outer diameter between 40 μm and 175 μm.

In some embodiments, the rotatable optical core comprises a single modeglass fiber with an outer diameter between 80 μm and 125 μm.

In some embodiments, the rotatable optical core comprises a polyimidecoating.

In some embodiments, the rotatable optical core comprises an outerdiameter between 60 μm and 175 μm. The rotatable optical core cancomprise an outer diameter of approximately 110 μm.

In some embodiments, the rotatable optical core comprises a materialselected from the group consisting of: silica glass; plastic;polycarbonate; and combinations thereof.

In some embodiments, the rotatable optical core comprises a numericalaperture of approximately 0.11.

In some embodiments, the rotatable optical core comprises a numericalaperture of at least 0.11.

In some embodiments, the rotatable optical core comprises a numericalaperture of approximately 0.16.

In some embodiments, the rotatable optical core comprises a numericalaperture of approximately 0.20.

In some embodiments, the rotatable optical core is constructed andarranged to rotate in a single direction.

In some embodiments, the rotatable optical core is constructed andarranged to rotate in two directions.

In some embodiments, the rotatable optical core is configured to beretracted within the elongate shaft. The system can further comprisepurge media introduced between the rotatable optical core and theelongate shaft. The purge media can provide a function selected from thegroup consisting of: index matching; lubrication; purging of bubbles;and combinations thereof.

In some embodiments, the optical assembly comprises an outer diameterbetween 80 μm and 500 μm. The optical assembly can comprise an outerdiameter of approximately 150 μm.

In some embodiments, the optical assembly comprises an outer diameter ofat least 125 μm.

In some embodiments, the optical assembly comprises a length between 200μm and 3000 μm. The optical assembly can comprise a length ofapproximately 1000 μm.

In some embodiments, the optical assembly comprises a lens. The lens cancomprise a GRIN lens. The lens can comprise a focal length between 0.5mm and 10.0 mm. The lens can comprise a focal length of approximately2.0 mm. The lens can comprise a ball lens.

In some embodiments, the optical assembly comprises a reflectingelement.

In some embodiments, the optical assembly comprises a lens, a reflectingelement and a connecting element, and the connecting element positionsthe reflecting element relative to the lens. The connecting element cancomprise an element selected from the group consisting of: tube;flexible tube; heat shrink; optically transparent arm; and combinationsthereof. The connecting element can position the reflecting element adistance of between 0.01 mm and 3.0 mm from the lens. The connectingelement can position the reflecting element a distance of between 0.01mm and 1.0 mm from the lens. The reflecting element can comprise acleaved portion of a larger assembly. The reflecting element cancomprise a segment of a wire. The wire can comprise a gold wire. Thelens can comprise a GRIN lens. The lens can have at least one of anouter diameter of 150 μm or a length of 1000 μm. The lens can furthercomprise a coreless lens positioned proximal to and optically connectedto the GRIN lens.

In some embodiments, the imaging probe comprises the inertial assembly,and the inertial assembly is positioned proximate the optical assembly.

In some embodiments, the imaging probe comprises the inertial assembly,and the inertial assembly further comprises a wound hollow core cablecomprising a proximal end and a distal end, the distal end of the woundhollow core cable being affixed to the rotatable optical core at alocation proximal to the optical assembly, and the proximal end of thewound hollow core cable being unattached to the optical core.

In some embodiments, the imaging probe comprises the inertial assembly,and the inertial assembly comprises fluid within the elongate shaftlumen and a mechanical resistance element positioned on the distalportion of the optical core, and the mechanical resistance element is incontact with the fluid and configured to resist rotation of therotatable optical core.

In some embodiments, the imaging probe comprises the inertial assembly,and the inertial assembly is constructed and arranged to provideinertial dampening which increases with rotational speed.

In some embodiments, the imaging probe comprises the inertial assembly,and the inertial assembly comprises a projection from the rotatableoptical core. The projection can be constructed and arranged tofrictionally engage the elongate shaft. The projection can beconstructed and arranged to cause shear force that applies a load to therotatable optical core during rotation.

In some embodiments, the imaging probe comprises the inertial assembly,and the inertial assembly comprises a projection from the elongateshaft. The projection can be constructed and arranged to frictionallyengage the rotatable optical core. The projection can be constructed andarranged to cause shear force that applies a load to the rotatableoptical core during rotation. The projection can be created by a thermalprocessing of the elongate shaft.

In some embodiments, the imaging probe comprises the inertial assembly,and the inertial assembly comprises a compressed portion from theelongate shaft. The system can further comprise at least one bandconfigured to crimp the elongate shaft to create the compressed portion.

In some embodiments, the imaging probe comprises the inertial assembly,and the inertial assembly comprises the impeller.

In some embodiments, the imaging probe comprises the impeller, and theimpeller is constructed and arranged to cause wind-up loading of therotatable optical core during rotation.

In some embodiments, the imaging probe comprises the impeller and theimaging probe further comprises fluid in a lumen, and the impeller isconfigured to engage the fluid during rotation of the rotatable opticalcore.

In some embodiments, the imaging probe comprises the impeller, and theimpeller comprises a turbine.

In some embodiments, the imaging probe comprises the impeller, and theimpeller is configured to frictionally engage the elongate shaft duringrotation of the rotatable optical core.

In some embodiments, the imaging probe comprises the impeller, and theimpeller comprises a vane-type micro structure.

In some embodiments, the imaging probe comprises the impeller, and theimpeller comprises a flywheel.

In some embodiments, the imaging probe comprises the stiffening element.

In some embodiments, the imaging probe comprises the stiffening element,and the stiffening element comprises a wire coil embedded in theelongate shaft, and the wire spiral geometry and a pullback spiralrotational pattern of the optical assembly are matched but offset byapproximately one-half of a wire spiral, such that an imaging beam ofthe optical assembly passes between the wire spirals during pullback.

In some embodiments, the imaging probe comprises the stiffening element,and the stiffening element comprises a wound wire formed over therotatable optical core.

In some embodiments, the imaging probe comprises the stiffening element,and the stiffening element comprises a stiffening member embedded in theelongate shaft, and the stiffening member geometry and a pullback spiralpattern of the optical assembly are matched but offset by approximatelyone-half of a wire spiral, such that an imaging beam of the opticalassembly passes between the wire spirals during pullback.

In some embodiments, the imaging probe comprises the reduced portion ofthe elongate shaft. The imaging probe can comprise at least one bandcrimped about the elongate shaft and constricting the elongate shaft tocreate the reduced portion of the elongate shaft. At least one band canprovide a seal to be formed between the rotatable core and the elongateshaft. The reduced portion of the elongate shaft can comprise athermally treated portion of the elongate shaft.

In some embodiments, the imaging probe further comprises a fluidpositioned within the lumen of the elongate shaft. The fluid can beconfigured to reduce variances in rotational speed of the rotatableoptical core. The system can further comprise a sealing elementpositioned proximate the proximal end of the elongate shaft, and theseal can be configured to maintain the fluid within the lumen. The fluidcan comprise a first fluid positioned around the optical assembly and asecond fluid positioned around the rotatable optical core. The firstfluid can comprise a first viscosity and the second fluid can comprise asecond viscosity greater than the first viscosity. The second fluid canbe constructed and arranged to reduce variances in rotational speed ofthe rotatable optical core. The system can further comprise a sealingelement positioned between the first fluid and the second fluid. Thefluid can comprise a gel. The fluid can comprise a shear-thinning fluid.The fluid can comprise a shear-thinning gel. The fluid can be configuredto provide lubrication. The fluid can be configured to cause therotatable optical core to tend to remain centered in the elongate shaftduring rotation of the rotatable optical core. The first fluid cancomprise a viscosity between 10 Pa-S and 100,000 Pa-S. The first fluidcan be configured to reduce in viscosity to a level of approximately 3Pa-S at a shear rate of 100 s-1. The fluid can comprise a lubricantconfigured to reduce friction between the rotatable optical core and theelongate shaft. The fluid can comprise a first fluid and a second fluid,and the second fluid can be positioned within the elongate shaftproximate the optical assembly, and the first fluid can be positionedwithin the elongate shaft proximal to the second fluid. The imagingprobe can further comprise a sealing element in between the first fluidand the second fluid. The sealing element can be positioned between 1 mmand 20 mm from the optical assembly. The sealing element can bepositioned approximately 3 mm from the optical assembly. The first fluidcan comprise a viscosity between 10 Pa-S and 100,000 Pa-S. The firstfluid can comprise a shear-thinning fluid. The first fluid can beconfigured to reduce in viscosity to a level of approximately 3 Pa-S ata shear rate of 100 s-1. The first fluid material can comprise a fluidselected from the group consisting of: hydrocarbon-based material;silicone; and combinations thereof. The second fluid can comprise aviscosity between 1 Pa-S and 100 Pa-S. The second fluid can comprise aviscosity of approximately 10 Pa-S. The second fluid can comprise afluid selected from the group consisting of: mineral oil; silicone; andcombinations thereof. The imaging system can be configured to pressurizethe fluid in the lumen. The imaging system can be constructed andarranged to perform the pressurization of the fluid to reduce bubbleformation and/or bubble growth. The imaging system can be configured topressurize the fluid in the lumen to a pressure of at least 100 psi. Theimaging system can comprise a pressurization assembly configured toperform the pressurization of the fluid. The pressurization assembly cancomprise a check valve. The fluid can comprise a lubricant. Thelubricant can be configured to reduce friction between the rotatableoptical core and the elongate shaft when at least a portion of theelongate shaft is positioned proximate and distal to the carotid artery.The fluid can comprise a high viscosity fluid. The elongate shaft can beconstructed and arranged to expand when the fluid is pressurized. Theelongate shaft can be constructed and arranged to expand to a firstinner diameter when the fluid is at a first pressure. The elongate shaftcan be constructed and arranged to expand to a second inner diameterwhen the fluid is at a second pressure. The elongate shaft can beconstructed and arranged to become more rigid when the fluid ispressurized. The elongate shaft can be constructed and arranged toincrease space between the rotatable optical core and the elongate shaftduring the expansion by the pressurized fluid. The elongate shaft can beconstructed and arranged to remain at least partially expanded when thefluid pressure is reduced.

In some embodiments, the imaging probe further comprises a torque shaftwith a proximal end and a distal end, and the torque shaft can befixedly attached to the rotatable optical core such that rotation of thetorque shaft rotates the rotatable optical core. The torque shaft cancomprise stainless steel. The torque shaft can comprise an outerdiameter between 0.02″ and 0.09″. The torque shaft can comprise an outerdiameter of approximately 0.025″. The torque shaft can comprise a lengthof approximately 49 cm. The torque shaft can comprise a dimensionselected from the group consisting of: an inner diameter ofapproximately 0.015″; an outer diameter of approximately 0.025″; andcombinations thereof. The torque shaft can comprise a wall thicknessbetween 0.003″ and 0.020″. The torque shaft can comprise a wallthickness of approximately 0.005″. The torque shaft distal end can bepositioned within 60 cm of the optical connector. The torque shaftdistal end can be positioned within 50 cm of the optical connector. Thetorque shaft distal end can be positioned at least 50 cm from theoptical assembly. The torque shaft distal end can be positioned at least100 cm from the optical assembly. The imaging system can furthercomprise a retraction assembly constructed and arranged to retract atleast one of the rotatable optical core or the elongate shaft, and thetorque shaft distal end can be positioned proximal to the retractionassembly. The imaging probe can further comprise a fixation tubepositioned between the torque shaft and the rotatable optical core. Thefixation tube can be adhesively attached to at least one of the torqueshaft or the rotatable optical core.

In some embodiments, the imaging system further comprises a visualizablemarker constructed and arranged to identify the location of the opticalassembly on a second image produced by a separate imaging device. Theseparate imaging device can comprise a device selected from the groupconsisting of: fluoroscope; ultrasonic imager; MM; and combinationsthereof. The visualizable marker can be positioned on the opticalassembly. The visualizable marker can be positioned at a fixed distancefrom the optical assembly. The imaging system can further comprise aconnecting element connecting the visualizable marker to the opticalassembly.

In some embodiments, the imaging probe can comprise multiple markersconstructed and arranged to provide a rule function. The at least one ofthe multiple markers can comprise at least one of a sealing element or arotational dampener. The multiple markers can comprise two or moremarkers selected from the group consisting of: radiopaque marker;ultrasonically reflective marker; magnetic marker; and combinationsthereof. The multiple markers can be positioned on the rotatable opticalcore. The multiple markers can be positioned on the elongate shaft.

In some embodiments, the imaging system further comprises a consolecomprising a component selected from the group consisting of: rotationassembly; retraction assembly; imaging assembly; algorithm; andcombinations thereof.

In some embodiments, the imaging system further comprises a rotationassembly constructed and arranged to rotate the rotatable optical core.The rotation assembly can comprise a motor. The imaging system canfurther comprise a retraction assembly constructed and arranged toretract at least one of the rotatable optical core or the elongateshaft. The imaging system can further comprise a translatable slide, andthe rotation assembly can be positioned on the translatable slide. Therotation assembly can be constructed and arranged to be positionedindependent of the position of the retraction assembly. The retractionassembly can be constructed and arranged to be positioned closer to thepatient than the rotation assembly. The rotation assembly can providemotive force to the retraction assembly. The rotation assembly cancomprise a drive cable that provides the motive force to the retractionassembly. The elongate shaft can be constructed and arranged to beretracted by the retraction assembly. The elongate shaft can comprise aproximal portion constructed and arranged to provide a service loopduring retraction by the retraction assembly. The rotation assembly canrotate the rotatable optical core at a rate between 20 rps and 2500 rps.The rotation assembly can rotate the rotatable optical core at a rate ofapproximately 250 rps. The rotation assembly can rotate the rotatableoptical core at a rate of up to 25,000 rps. The rotation assembly can beconstructed and arranged to rotate the rotatable optical core at avariable rate of rotation. The imaging system can further comprise asensor configured to produce a signal, and the rotational rate can bevaried based on the sensor signal. The sensor signal represents aparameter selected from the group consisting of: tortuosity of vessel;narrowing of vessel; presence of clot; presence of an implanted device;and combinations thereof. The rotation assembly can be configured toallow an operator to vary the rate of rotation. The rotation assemblycan be configured to automatically vary the rate of rotation. Therotation assembly can be configured to increase the rate of rotationwhen collecting image data from a target area.

In some embodiments, the imaging system further comprises a retractionassembly constructed and arranged to retract at least one of therotatable optical core or the elongate shaft. The retraction assemblycan be constructed and arranged to retract the rotatable optical corewithout retracting the elongate shaft. The retraction assembly can beconstructed and arranged to retract both the rotatable optical core andthe elongate shaft. The retraction assembly can be constructed andarranged to retract the rotatable optical core and the elongate shaftsimultaneously. The retraction assembly can be constructed and arrangedto retract the rotatable optical core and the elongate shaft in unison.The imaging probe can comprise a fluid between the rotatable opticalcore and the elongate shaft, and the retraction assembly can beconstructed and arranged to perform the retraction while minimizingbubble formation in the fluid. The elongate shaft distal portion cancomprise an optically transparent window, and the optical assembly canbe positioned within the optically transparent window. The opticallytransparent window can comprise a length of less than or equal to 6 mm,less than or equal to 15 mm, or less than or equal to 20 mm. Theoptically transparent window can comprise a length of between 5 mm and50 mm. The optically transparent window can comprise a length ofapproximately 10 mm, or approximately 12 mm. The optically transparentwindow can comprise a length of less than or equal to 4 mm. Theoptically transparent window can comprise a length of approximately 3mm. The elongate shaft can comprise an outer diameter less than or equalto 0.025″. The elongate shaft can comprise an outer diameter less thanor equal to 0.016″. The elongate shaft can comprise an outer diameterless than or equal to 0.014″. The retraction assembly can be constructedand arranged to retract the elongate shaft. The elongate shaft cancomprise a proximal portion constructed and arranged to provide aservice loop during retraction by the retraction assembly. Theretraction assembly can comprise a telescoping retraction assembly. Thetelescoping retraction assembly can comprise a disposable motor. Theimaging probe can comprise a Tuohy valve and the retraction assembly canoperably engage the Tuohy valve during retraction. The retractionassembly can be configured to perform a retraction over a time period ofbetween 0.1 seconds and 10 seconds. The retraction assembly can beconfigured to perform a retraction over a time period of approximately 4seconds. The retraction assembly can be constructed and arranged toretract the at least one of the rotatable optical core or the elongateshaft over a distance of approximately 50 mm. The retraction assemblycan be constructed and arranged to retract the at least one of therotatable optical core or the elongate shaft over a distance ofapproximately 75 mm. The retraction assembly can be constructed andarranged to retract the at least one of the rotatable optical core orthe elongate shaft over a distance of between 20 mm and 150 mm. Theretraction assembly can be constructed and arranged to have itsretraction distance selected by an operator of the system. Theretraction assembly can be configured to perform the retraction at arate between 3 mm/sec and 500 mm/sec. The retraction assembly can beconfigured to perform the retraction at a rate of approximately 50mm/sec. The retraction assembly can be constructed and arranged toretract the at least one of the rotatable optical core or the elongateshaft at a variable rate of retraction. The imaging system can furthercomprise a sensor configured to produce a signal, and the retractionrate can be varied based on the sensor signal. The sensor signal canrepresent a parameter selected from the group consisting of: tortuosityof vessel; narrowing of vessel; presence of clot; presence of animplanted device; and combinations thereof. The retraction assembly canbe configured to allow an operator to vary the retraction rate. Theretraction assembly can be configured to automatically vary theretraction rate. The retraction assembly can be configured to decreasethe rate of retraction when visualizing a target area. The imagingsystem can further comprise a catheter device comprising at least one ofa vascular introducer or a guide catheter, the elongate shaft insertablethrough the catheter device, and the retraction assembly can beattachable to the catheter device. The imaging system can furthercomprise a catheter device comprising at least one of a vascularintroducer or a guide catheter, the elongate shaft insertable throughthe catheter device, and the retraction assembly can be constructed andarranged to be positioned within 20 cm from the catheter device.

In some embodiments, the imaging system further comprises an imagingassembly configured to provide light to the rotatable optical core andto collect light from the rotatable optical core. The imaging assemblycan comprise a light source configured to provide the light to therotatable optical core. The imaging assembly can comprise a fiber opticrotary joint comprising an optical core configured to transmit light tothe rotatable optical core and receive light from the rotatable opticalcore. The rotatable optical core can comprise a fiber with a firstnumerical aperture, and the imaging assembly can comprise an imagingassembly optical core with a second numerical aperture different thanthe first numerical aperture. The first numerical aperture can beapproximately 0.16 and the second numerical aperture can beapproximately 0.11. The imaging system can further comprise an adaptorconfigured to attach the imaging probe to the imaging assembly. Theadaptor can comprise a lens assembly configured to match differentnumerical apertures. The adaptor can be configured to be used inmultiple clinical procedures, but in less procedures than the imagingassembly. The adaptor can comprise a fiber with a numerical aperturechosen to minimize coupling losses between the imaging probe and theimaging assembly. The numerical aperture of the adaptor fiber can beapproximately equal to the geometrical mean of the numerical aperture ofthe rotatable optical core and the numerical aperture of the imagingassembly. The numerical aperture of the adaptor fiber can beapproximately equal to the arithmetic mean of the numerical aperture ofthe rotatable optical core and the numerical aperture of the imagingassembly.

In some embodiments, the imaging system further comprises an algorithm.The imaging system can further comprise a sensor configured to produce asignal, and the algorithm can be configured to analyze the sensorsignal. The sensor signal can represent light collected from tissue. Thesensor signal can represent a parameter related to: tortuosity of ablood vessel; narrowing of a blood vessel; presence of clot; presence ofimplanted device; and combinations thereof.

In some embodiments, the imaging system further comprises at least oneguide catheter configured to slidingly receive the imaging probe. Theimaging system can further comprise a flushing fluid delivery assemblyconfigured to deliver a flushing fluid between the at least one guidecatheter and the imaging probe. The flushing fluid can comprise salineand/or contrast (e.g. radiopaque contrast). The flushing fluid deliveryassembly can be configured to deliver flushing fluid at a rate ofapproximately 6 ml/sec. The imaging system can further comprise theflushing fluid, and the flushing fluid can comprise iodinated contrastincluding an iodine concentration between 50 mg/ml and 500 mg/ml. Theflushing fluid can comprise a fluid whose viscosity ranges from 1.0 Cpto 20 Cp at a temperature of approximately 37° C. The at least one guidecatheter can comprise a first guide catheter comprising an opticallytransparent window, and the optical assembly can be constructed andarranged to be positioned within the optically transparent window. Thefirst guide catheter can comprise a microcatheter with an inner diameterbetween 0.021″ and 0.027″. The first guide catheter can comprise amicrocatheter with an inner diameter between 0.0165″ and 0.027″. The atleast one guide catheter can further comprise a second guide catheterconfigured to slidingly receive the first guide catheter.

In some embodiments, the imaging system further comprises a torque toolconstructed and arranged to operably engage the elongate shaft andsubsequently apply torsional force to the elongate shaft.

According to another aspect of the present inventive concepts, methodsof using the imaging system described herein are provided.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages of embodimentsof the present inventive concepts will be apparent from the moreparticular description of preferred embodiments, as illustrated in theaccompanying drawings in which like reference characters refer to thesame or like elements. The drawings are not necessarily to scale,emphasis instead being placed upon illustrating the principles of thepreferred embodiments.

FIG. 1 is a schematic view of an imaging system comprising an imagingprobe, an imaging console and one or more delivery devices, consistentwith the present inventive concepts.

FIG. 1A is magnified view of the distal portion of the shaft of theimaging probe of FIG. 1, consistent with the present inventive concepts.

FIG. 2 is a perspective view of an imaging probe comprising a metal coilin a distal portion of its shaft, consistent with the present inventiveconcepts.

FIG. 3 is a chart illustrating non-uniform rotational distortion.

FIG. 4 is a side sectional view of the distal portion of an imagingprobe comprising a thin walled segment of shaft about an opticalassembly, consistent with the present inventive concepts.

FIG. 5 is a side sectional view of the distal portion of an imagingprobe comprising two fluids within the shaft of the imaging probe,consistent with the present inventive concepts.

FIG. 6 is a perspective view of an impeller, and a side sectional viewof a distal portion of an imaging probe comprising the impeller,consistent with the present inventive concepts.

FIG. 7 is a side sectional view of a proximal portion of an imagingprobe comprising a pressurization element, consistent with the presentinventive concepts.

FIG. 8 is a side sectional anatomical view of a system comprising aguide catheter, an imaging probe and a treatment device, each of whichhaving been placed into a vessel of the patient, consistent with thepresent inventive concepts.

FIG. 9 is a side sectional anatomical view of the system of FIG. 8,after the guide catheter has been partially retracted, consistent withthe present inventive concepts.

FIG. 10 is a side sectional anatomical view of the system of FIG. 8,after the imaging probe has been advanced through the treatment device,consistent with the present inventive concepts.

FIG. 11 is a side sectional anatomical view of the system of FIG. 8, asthe imaging probe is being retracted through the treatment device,consistent with the present inventive concepts.

FIG. 12 is a side sectional anatomical view of a system comprising animaging probe and a treatment device, consistent with the presentinventive concepts.

FIG. 13 is a side sectional view of an imaging probe comprisingprecision spacing between a rotatable optical core and a shaft, thespacing configured to provide capillary action to a fluid, consistentwith the present inventive concepts.

FIG. 14 is partially assembled view of an imaging probe comprising ashaft, rotatable optical core, and torque shaft, consistent with thepresent inventive concepts.

FIG. 15A-C are side sectional views of an imaging probe in a series ofexpansion steps of its shaft via an internal fluid, consistent with thepresent inventive concepts.

FIG. 16 is a side sectional view of the distal portion of an imagingprobe comprising a distal marker positioned in reference to an opticalassembly, consistent with the present inventive concepts.

FIG. 17 is a side sectional view of the distal portion of an imagingprobe comprising two sealing elements, consistent with the presentinventive concepts.

FIG. 18 is a side sectional view of the distal portion of an imagingdevice comprising a lens and deflector separated and connected by aprojection, consistent with the present inventive concepts.

DETAILED DESCRIPTION OF THE DRAWINGS

The terminology used herein is for the purpose of describing particularembodiments and is not intended to be limiting of the inventiveconcepts. Furthermore, embodiments of the present inventive concepts mayinclude several novel features, no single one of which is solelyresponsible for its desirable attributes or which is essential topracticing an inventive concept described herein. As used herein, thesingular forms “a,” “an” and “the” are intended to include the pluralforms as well, unless the context clearly indicates otherwise.

It will be further understood that the words “comprising” (and any formof comprising, such as “comprise” and “comprises”), “having” (and anyform of having, such as “have” and “has”), “including” (and any form ofincluding, such as “includes” and “include”) or “containing” (and anyform of containing, such as “contains” and “contain”) when used herein,specify the presence of stated features, integers, steps, operations,elements, and/or components, but do not preclude the presence oraddition of one or more other features, integers, steps, operations,elements, components, and/or groups thereof.

It will be understood that, although the terms first, second, third etc.may be used herein to describe various limitations, elements,components, regions, layers and/or sections, these limitations,elements, components, regions, layers and/or sections should not belimited by these terms. These terms are only used to distinguish onelimitation, element, component, region, layer or section from anotherlimitation, element, component, region, layer or section. Thus, a firstlimitation, element, component, region, layer or section discussed belowcould be termed a second limitation, element, component, region, layeror section without departing from the teachings of the presentapplication.

It will be further understood that when an element is referred to asbeing “on”, “attached”, “connected” or “coupled” to another element, itcan be directly on or above, or connected or coupled to, the otherelement, or one or more intervening elements can be present. Incontrast, when an element is referred to as being “directly on”,“directly attached”, “directly connected” or “directly coupled” toanother element, there are no intervening elements present. Other wordsused to describe the relationship between elements should be interpretedin a like fashion (e.g., “between” versus “directly between,” “adjacent”versus “directly adjacent,” etc.).

It will be further understood that when a first element is referred toas being “in”, “on” and/or “within” a second element, the first elementcan be positioned: within an internal space of the second element,within a portion of the second element (e.g. within a wall of the secondelement); positioned on an external and/or internal surface of thesecond element; and combinations of one or more of these.

Spatially relative terms, such as “beneath,” “below,” “lower,” “above,”“upper” and the like may be used to describe an element and/or feature'srelationship to another element(s) and/or feature(s) as, for example,illustrated in the figures. It will be understood that the spatiallyrelative terms are intended to encompass different orientations of thedevice in use and/or operation in addition to the orientation depictedin the figures. For example, if the device in a figure is turned over,elements described as “below” and/or “beneath” other elements orfeatures would then be oriented “above” the other elements or features.The device can be otherwise oriented (e.g., rotated 90 degrees or atother orientations) and the spatially relative descriptors used hereininterpreted accordingly.

The term “and/or” where used herein is to be taken as specificdisclosure of each of the two specified features or components with orwithout the other. For example “A and/or B” is to be taken as specificdisclosure of each of (i) A, (ii) B and (iii) A and B, just as if eachis set out individually herein.

As described herein, “room pressure” shall mean pressure of theenvironment surrounding the systems and devices of the present inventiveconcepts. Positive pressure includes pressure above room pressure orsimply a pressure that is greater than another pressure, such as apositive differential pressure across a fluid pathway component such asa valve. Negative pressure includes pressure below room pressure or apressure that is less than another pressure, such as a negativedifferential pressure across a fluid component pathway such as a valve.Negative pressure can include a vacuum but does not imply a pressurebelow a vacuum. As used herein, the term “vacuum” can be used to referto a full or partial vacuum, or any negative pressure as describedhereabove.

The term “diameter” where used herein to describe a non-circulargeometry is to be taken as the diameter of a hypothetical circleapproximating the geometry being described. For example, when describinga cross section, such as the cross section of a component, the term“diameter” shall be taken to represent the diameter of a hypotheticalcircle with the same cross sectional area as the cross section of thecomponent being described. Shafts of the present inventive concepts,such as hollow tube shafts comprising a lumen and a wall, include aninner diameter (ID) equal to the diameter of the lumen, and an outerdiameter (OD) defined by the outer surface of the shaft.

The terms “major axis” and “minor axis” of a component where used hereinare the length and diameter, respectively, of the smallest volumehypothetical cylinder which can completely surround the component.

The term “transducer” where used herein is to be taken to include anycomponent or combination of components that receives energy or anyinput, and produces an output. For example, a transducer can include anelectrode that receives electrical energy, and distributes theelectrical energy to tissue (e.g. based on the size of the electrode).In some configurations, a transducer converts an electrical signal intoany output, such light (e.g. a transducer comprising a light emittingdiode or light bulb), sound (e.g. a transducer comprising a piezocrystal configured to deliver ultrasound energy), pressure, heat energy,cryogenic energy, chemical energy; mechanical energy (e.g. a transducercomprising a motor or a solenoid), magnetic energy, and/or a differentelectrical signal (e.g. a Bluetooth or other wireless communicationelement). Alternatively or additionally, a transducer can convert aphysical quantity (e.g. variations in a physical quantity) into anelectrical signal. A transducer can include any component that deliversenergy and/or an agent to tissue, such as a transducer configured todeliver one or more of: electrical energy to tissue (e.g. a transducercomprising one or more electrodes); light energy to tissue (e.g. atransducer comprising a laser, light emitting diode and/or opticalcomponent such as a lens or prism); mechanical energy to tissue (e.g. atransducer comprising a tissue manipulating element); sound energy totissue (e.g. a transducer comprising a piezo crystal); chemical energy;electromagnetic energy; magnetic energy; and combinations of one or moreof these.

As used herein, the term “patient site” refers to a location within thepatient, such as a location within a body conduit such as a blood vessel(e.g. an artery or vein) or a segment of the GI tract (e.g. theesophagus, stomach or intestine), or a location with an organ. A“patient site” can refer to a location in the spine, such as within theepidural space or intrathecal space of the spine. A patient site caninclude a location including one or more of: an aneurysm; a stenosis;thrombus and/or an implant.

As used herein, the term “neural site” refers to a patient siteproximate the brain, such as at a location within the neck, head orbrain of a patient. A neural site can include a location proximate thebrain including one or more of: an aneurysm; a stenosis; thrombus and/oran implant.

As used herein, the term “proximate” shall include locations relativelyclose to, on, in and/or within a referenced component or other location.

As used herein, the term “transparent” and “optically transparent” referto a property of a material that is relatively transparent (e.g. notopaque) to light delivered and/or collected by one or more components ofthe imaging system or probe of the present inventive concepts (e.g. tocollect image data of a patient site).

It is appreciated that certain features of the inventive concepts, whichare, for clarity, described in the context of separate embodiments, mayalso be provided in combination in a single embodiment. Conversely,various features of the inventive concepts which are, for brevity,described in the context of a single embodiment, may also be providedseparately or in any suitable sub-combination. For example, it will beappreciated that all features set out in any of the claims (whetherindependent or dependent) can be combined in any given way.

The present inventive concepts include imaging systems comprisingimaging probes and one or more delivery devices, such as deliverycatheters and/or guidewires. The imaging probe can be configured to bepositioned proximate a patient site and to collect image data from thepatient site, such as a neural site, spinal site and/or other patientsite as defined hereabove. The imaging probe comprises an elongate shaftincluding a lumen. In some embodiments, a rotatable optical core and adistally positioned optical assembly are positioned within the lumen ofthe probe shaft. A probe connector can be positioned on the proximal endof the elongate shaft, the connector surrounding at least a portion ofthe rotatable optical core (e.g. the proximal end of the rotatableoptical core). The present inventive concepts further includes methodsof introducing the imaging probe to a patient site, such as a neuralsite, using one or more delivery devices such as delivery cathetersand/or guidewires. In some embodiments, the imaging probe is advancedthrough a delivery catheter to a patient site, without being advancedover a guidewire.

In some embodiments, the imaging probe comprises an inertial assemblyconfigured to reduce rotational speed variances of the rotatable opticalcore. In some embodiments, the imaging probe comprises an impellerattached to the rotatable optical core and configured to resist rotationof the rotatable optical core, such as when the rotatable optical coreis retracted.

In some embodiments, the imaging probe comprises a reinforcing assemblyembedded into the elongate shaft. The reinforcing assembly can beconfigured to resist flexing of the elongate shaft and can comprise anoptically transparent portion.

In some embodiments, the imaging probe comprises an elongate shaft inwhich at least a portion of the shaft includes a reduced inner diameteror otherwise comprises a portion in which the gap between the elongateshaft and the rotatable optical core is reduced. The reduced gap portioncan be configured to reduce rotational speed variances of the rotatableoptical core. In some embodiments, the reduced gap portion causes theelongate shaft to frictionally engage the rotatable optical core,providing a dampening force configured to reduce undesired speedvariances of the rotatable optical core (e.g. to avoid undesiredrotational speed variances in the attached optical assembly 130).Alternatively or additionally, a fluid can be positioned in the reducedgap portion (or other locations between the elongate shaft and therotatable optical core), such as to similarly reduce undesired speedvariances of the rotatable optical core. The fluid can comprise ashear-thinning fluid configured to avoid excessive loading on therotatable optical core (e.g. during high speed rotation to preventbreaking of the rotatable optical core).

Systems, devices and methods of the present inventive concepts can beused to diagnose and/or treat stroke. Stroke is the 4th-leading cause ofdeath in the United States and leads all ailments in associateddisability costs. Stroke is a result of vascular disease and comes intwo major forms: ischemic, in which the blood supply to the brain isinterrupted; and hemorrhagic, in which a ruptured vessel leaks blooddirectly in the brain tissue. Both forms have associated high morbidityand mortality, such that improved diagnosis and treatment would have asignificant impact on healthcare costs.

Imaging of the vessels is the primary diagnostic tool when planning andapplying therapies such as: thrombolytic drugs or stent retrievers forclot removal (ischemic stroke); or coils, flow diverters and otherdevices for aneurysm repair (hemorrhagic stroke). External,non-invasive, imaging technologies, such as x-ray, angiography or MRI,are the primary imaging techniques used, but such techniques providelimited information such as vessel size and shape information withmoderate resolution (e.g. approximately 200 μm resolution). Such levelsof resolution do not permit the imaging of important smaller perforatorvessels present in the vasculature. An inability to adequately imagethese vessels limits pre-procedural planning as well as acute assessmentof therapeutic results. These imaging technologies are further limitedin their effectiveness due to the shadowing and local image obliterationthat can be created by the therapies themselves (e.g. in the case ofimplantation of one or more coils). Thus there is a desire to alsoperform intravascular imaging to examine the detailed morphology of theinterior vessel wall and/or to better plan and assess the results ofcatheter based interventions. Currently, intravascular imagingtechniques such as Intravascular Ultrasound (IVUS) and intravascularOptical Coherence Tomography (OCT) have been developed, but are onlyapproved for use in the coronary arteries. IVUS is also used in thelarger peripheral vasculature. Currently, intravascular imaging has notbeen extended for use into the neurological vessels except for thelarger carotid arteries. The limitations of current technologiescorrelate to: the neurological vessel sizes can become very small, onthe order of 1 mm in diameter or less, and the vessel tortuosity becomesquite high (e.g. if attempting to navigate the tortuous carotid sinus toreach and image the mid-cranial artery as well as branches and segmentsabove).

Due to the fundamental limits of ultrasound resolution, especially theunavoidable beam spreading when small transducers are used, opticaltechniques are more appropriate. In particular, with the advent of newlight sources such as broad band SLED's, visible wavelength laserdiodes, and compact swept-frequency light sources, which are allcompatible with single-mode fibers and interferometric imaging such asOCT, the use of optical techniques is highly advantageous both from aclinical performance as well as commercial viewpoint. The use of singlemode fibers allows small diameter imaging catheters.

Referring now to FIG. 1, a schematic view of an imaging systemcomprising an imaging probe and one or more delivery devices isillustrated, consistent with the present inventive concepts. System 10is constructed and arranged to collect image data and produce an imagebased on the recorded data, such as when system 10 comprises an OpticalCoherence Tomogrophy (OCT) imaging system. System 10 comprises imagingprobe 100, and at least one delivery device, such as at least onedelivery catheter 50 and/or at least one guidewire 60. System 10 canfurther comprise an imaging console, console 200 which is configured tooperably attach to imaging probe 100. System 10 can further comprise afluid injector, such as injector 300 which can be configured to injectone or more fluids, such as a flushing fluid, an imaging contrast agent(e.g. a radiopaque contrast agent, hereinafter “contrast”) and/or otherfluid, such as injectate 305 shown. System 10 can further comprise animplant, such as implant 85 which can be implanted in the patient viaimplant delivery device 80. System 10 can further comprise a deviceconfigured to treat the patient, treatment device 91, which can beconfigured to dilate a stenotic site, remove stenotic material (e.g.thrombus) and/or otherwise treat a patient disease or disorder. System10 can further comprise a second imaging device, such as imaging device92 shown.

Imaging probe 100 comprises an elongate shaft, shaft 110, comprisingproximal end 111, distal end 119, proximal portion 111 a, a middleportion (mid portion 115), and distal portion 119 a. An opticalconnector, connector 102 is positioned on the proximal end 111 of shaft110, such as a connector configured to operably attach probe 100 toconsole 200. Imaging probe 100 is configured to provide a patient image,such as a three dimensional (3D) image created when shaft 110 of imagingprobe 100 is retracted. In some embodiments, imaging probe 100 and/oranother component of system 10 is of similar construction andarrangement to the similar components described in applicant'sco-pending U.S. Provisional Application Ser. No. 62/148,355, titled“Micro-Optic Probes for Neurology”, filed Apr. 29, 2015, the content ofwhich is incorporated herein in its entirety for all purposes.

Imaging system 10 can comprise one or more imaging probes 100, eachsuitable for imaging highly tortuous bodily lumens such as themid-cranial artery, various peripheral arteries, and ducts of theendocrine system such as the liver (bile) and pancreatic ducts. Eachimaging probe 100 can comprise very small cross-sections, typically lessthan 1 mm in OD and contain a rotatable optical core, core 120comprising a single fiber optically connected on its distal end to anoptical assembly, optical assembly 130. Core 120 is rotated to create ahigh fidelity image of the luminal wall through which probe 100 isinserted. Imaging probe 100 and other components of imaging system 10can be configured to facilitate uniform rotational velocity of core 120while imaging probe 100 traverses difficult anatomies. Imaging system 10can comprise multiple imaging probes 100 provided in a kitconfiguration, such as when two or more probes 100 comprise differentcharacteristics (e.g. different length, diameter and/or flexibility)

Imaging probe 100 is constructed and arranged to collect image data froma patient site. Distal portion 119 a can be configured to pass throughthe patient site, such as a patient site including occlusive materialsuch as thrombus or a patient site including an implant. In someembodiments, probe 100 is constructed and arranged to collect image datafrom a neural site, such as a neural site selected from the groupconsisting of: artery of patient's neck; vein of patient's neck; arteryof patient's head; vein of patient's head; artery of patient's brain;vein of patient's brain; and combinations of one or more of these. Insome embodiments, probe 100 is constructed and arranged to collect imagedata from one or more locations along or otherwise proximate thepatient's spine. In some embodiments, probe 100 is constructed andarranged to collect image data from tissue selected from the groupconsisting of: wall tissue of a blood vessel of the patient site;thrombus proximate the patient site; occlusive matter proximate thepatient site; a blood vessel outside of blood vessel in which opticalassembly 130 is positioned; tissue outside of blood vessel in whichoptical assembly 130 is positioned; extracellular deposits outside ofthe lumen of the blood vessel in which optical assembly 130 ispositioned (e.g. within and/or outside of the blood vessel wall); andcombinations of one or more of these. Alternatively or additionally,optical assembly 130 can be constructed and arranged to collect imagedata from an implanted device (e.g. a temporary or chronically implanteddevice), such as implant 85 described herebelow or a device previouslyimplanted in the patient. In some embodiments, optical assembly 130 isconstructed and arranged to collect image data regarding the placementprocedure in which the implant was positioned within the patient (e.g.real time data collected during placement). Optical assembly 130 can beconstructed and arranged to collect implant data comprising positionand/or expansion data related to placement of an implant or othertreatment device, such as a device selected from the group consistingof: a stent retriever (also known as a stentriever); an embolizationdevice such as an embolization coil; an embolization coil deliverycatheter; an occlusion device; a stent; a covered stent; a stentdelivery device; a flow diverter; an aneurysm treatment device; ananeurysm delivery device; a balloon catheter; and combinations of one ormore of these. In some embodiments, optical assembly 130 is constructedand arranged to collect data related to the position of an implant 85 orother device comprising a stimulation element, such as an electrode orother stimulation element positioned proximate the brain (e.g. anelectrode positioned in the deep brain or other brain location) or astimulation element positioned proximate the spine (e.g. stimulationelement configured to treat pain by stimulating spine tissue).Implantation of implant 85 can be performed based on an analysis ofcollected image data (e.g. an analysis of collected image data byalgorithm 240). The analysis can be used to modify an implantationparameter selected from the group consisting of: selection of theimplantable device (e.g. selection of implant 85); selection of theimplantable device porosity; selection of the implantable device metalcoverage; selection of the implantable device pore density; selection ofthe implantable device diameter; selection of the implantable devicelength; selection of the location to implant the implantable device; adilation parameter for expanding the implantable device once implanted;a repositioning of the implantable device once implanted; selection of asecond implantable device to be implanted; and combinations thereof. Anadjustment of the implantation can be performed based on one or moreissues identified in the analysis, such as an issue selected from thegroup consisting of: malposition of implanted device; inadequatedeployment of implanted device; presence of air bubbles; andcombinations thereof.

In some embodiments, optical assembly 130 is constructed and arranged tocollect data related to the position of a treatment device, such astreatment device 91 described herebelow, during a patient treatmentprocedure.

Delivery catheters 50 can comprise one or more delivery catheters, suchas delivery catheters 50 a, 50 b, 50 c through 50 n shown. Deliverycatheters 50 can include a vascular introducer, such as when deliverycatheter 50 a shown in FIG. 1 comprises a vascular introducer, deliverycatheter 50 _(INTRO). Other delivery catheters 50 can be inserted intothe patient through delivery catheter 50 _(INTRO), after the vascularintroducer is positioned through the skin of the patient. Two or moredelivery catheters 50 can collectively comprise sets of inner diameters(IDs) and outer diameters (ODs) such that a first delivery catheter 50slidingly receives a second delivery catheter 50 (e.g. the seconddelivery catheter OD is less than or equal to the first deliverycatheter ID), and the second delivery catheter 50 slidingly receives athird delivery catheter 50 (e.g. the third delivery catheter OD is lessthan or equal to the second delivery catheter ID), and so on. In theseconfigurations, the first delivery catheter 50 can be advanced to afirst anatomical location, the second delivery catheter 50 can beadvanced through the first delivery catheter to a second anatomicallocation distal or otherwise remote (hereinafter “distal”) to the firstanatomical location, and so on as appropriate, using sequentiallysmaller diameter delivery catheters 50.

Each delivery catheter 50 comprises a shaft 51 (e.g. shafts 51 a, 51 b,51 c and 51 n shown), each with a distal end 59 (e.g. distal ends 59 a,59 b, 59 c and 59 n shown). A connector 55 (e.g. connectors 55 a, 55 b,55 c and 55 n shown) is positioned on the proximal end of each shaft 51.Each connector 55 can comprise a Touhy or other valved connector, suchas a valved connector configured to prevent fluid egress from theassociated catheter 50 (with and/or without a separate shaft positionedwithin the connector 55). Each connector 55 can comprise a port 54 asshown on delivery catheters 50 b, 50 c, and 50 n, such as a portconstructed and arranged to allow introduction of fluid into theassociated delivery catheter 50 and/or for removing fluids from anassociated delivery catheter 50. In some embodiments, a flushing fluid,as described herebelow, is introduced via one or more ports 54, such asto remove blood or other undesired material from locations proximateoptical assembly 130. Port 54 can be positioned on a side of connector55 and can include a luer fitting and a cap and/or valve. Shafts 51,connectors 55 and ports 54 can each comprise standard materials and beof similar construction to commercially available introducers, guidecatheters, diagnostic catheters, intermediate catheters andmicrocatheters used in interventional procedures.

Each delivery catheter 50 comprises a lumen 52 (reference number 52shown on delivery catheter 50 a but removed from the remaining deliverycatheters 50 for illustrative clarity) extending from the connector 55to the distal end 59 of shaft 51. The diameter of each lumen 52 definesthe ID of the associated delivery catheter 50. Each delivery catheter 50can be advanced over a guidewire (e.g. guidewire 60) via lumen 52. Insome embodiments, a delivery catheter 50 is configured for rapidexchange advancement and retraction over a guidewire, such as via asidecar with a rapid exchange (Rx) guidewire lumen as is known to thoseof skill in the art. In some embodiments, probe 100 and at least onedelivery catheter 50 are cooperatively constructed and arranged suchthat the delivery catheter 50 is advanced through a vessel, such as ablood vessel, and probe 100 is slidingly received by the deliverycatheter 50 and advanced through the delivery catheter 50 to a locationproximate a patient site PS to be imaged (e.g. a location just distalto, within and/or just proximate the patient site PS to be imaged). Insome embodiments, a second delivery catheter 50 is slidingly received bya first delivery catheter 50, and probe 100 is advanced through thesecond delivery catheter 50 to a location proximate a patient site PS tobe imaged. In yet other embodiments, three or more delivery catheters 50are coaxially inserted in each other, with probe 100 advanced throughthe innermost delivery catheter 50 to a location proximate a patientsite PS to be imaged. In some embodiments, probe 100 is advanced through(e.g. through and beyond) one or more delivery catheters 50 without theuse of a guidewire.

Delivery catheters 50 can comprise one or more delivery cathetersselected from the group consisting of: an introducer; a vascularintroducer; an introducer with an ID between 7 Fr and 9 Fr; a deliverycatheter (also referred to as a guide catheter) for positioning throughthe aortic arch (e.g. such that its distal end is just distal orotherwise proximate the aortic arch) such as a delivery catheter with anID between 5 Fr and 7 Fr or an ID of approximately 6.5 Fr; a deliverycatheter (also referred to as an intermediate catheter) for insertionthrough a larger, previously placed delivery catheter, such as anintermediate delivery catheter with an ID of between 0.053″ and 0.070″;a delivery catheter (also referred to as a microcatheter) with an ID ofbetween 0.0165″ and 0.027″; and combinations of one or more of these. Insome embodiments, delivery catheters 50 comprise a first deliverycatheter 50 _(INTRO) comprising an introducer, such as an introducerwith an ID of between 7 Fr and 9 Fr or an ID of approximately 8 Fr.Delivery catheters 50 further can further comprise a second deliverycatheter 50 constructed and arranged to be inserted into the firstdelivery catheter 50, such as a second delivery catheter 50 _(GUIDE)constructed and arranged for positioning through the aortic arch andcomprising an ID between 5 Fr and 7 Fr or an ID of approximately 6 Fr.Delivery catheters 50 can comprise a third delivery catheter 50constructed and arranged to be inserted through the first deliverycatheter 50 _(INTRO) and/or the second delivery catheter 50 _(GUIDE),such as a third delivery catheter 50 _(INTER) (e.g. an intermediatecatheter) with an ID of between 0.053″ and 0.070″. Delivery catheters 50can comprise a fourth delivery catheter 50 _(MICRO) constructed andarranged to be inserted through the first, second and/or third deliverycatheters 50, such as a fourth delivery catheter 50 _(MICRO) with an IDof between 0.0165″ to 0.027″. Imaging probe 100 can be constructed andarranged to be inserted through first, second, third and/or fourthdelivery catheters 50, such as when imaging probe 100 comprises an OD ofless than 0.070″, such as when at least the distal portion of imagingprobe 100 comprises an OD of less than or equal to 0.025″, 0.022″,0.018″, 0.016″, 0.015″ or 0.014″. In some embodiments, at least thedistal portion of imaging probe 100 comprises an ID of approximately0.014″ (e.g. an ID between 0.012″ and 0.016″). In some embodiments,system 10 comprises a probe 100 and one or more delivery catheters 50.

Each delivery catheter 50 can comprise an optically transparent segment,such as a segment relatively transparent to light transmitted and/orreceived by optical assembly 130, such as transparent segment 57 shownon delivery catheter 50 n and described herein. Transparent segment 57can comprise a length of up to 50 cm, such as a length of between 1 cmand 15 cm, or a length of up to 2 cm or up to 5 cm. Transparent segment57 can be part of a delivery catheter 50 comprising a microcatheter withan ID between 0.0165″ and 0.027″, or between 0.021″ and 0.027″. System10 can comprise a first delivery catheter 50 that slidingly receivesprobe 100 and includes a transparent segment 57, and a second deliverycatheter 50 that slidingly receives the first delivery catheter 50.

Each delivery catheter 50 can comprise a spring tip, not shown but suchas spring tip 104 described herein as attached to shaft 110 of probe100.

Guidewires 60 can comprise one or more guidewires, such as guidewires 60a, 60 b through 60 n shown. Guidewires 60 can comprise one or moreguidewires constructed and arranged to support advancement (e.g.intravascular advancement) of probe 100 (e.g. via a rapid exchange lumenin distal portion 119 a of shaft 110) and/or a delivery catheter 50 intoa patient site PS such as a neural site. Guidewires 60 can comprise oneor more guidewires selected from the group consisting of: a guidewirewith an OD between 0.035″ and 0.038″; a guidewire with an OD between0.010″ and 0.018″; an access length guidewire such as a guidewire with alength of approximately 200 cm; an exchange length guidewire such as aguidewire with a length of approximately 300 cm; a guidewire with alength between 175 cm and 190 cm; a guidewire with a length between 200cm and 300 cm and/or an OD between 0.014″ and 0.016″; a hydrophilicguidewire; a Stryker Synchro™ guidewire; a Terumo guidewire such as theTerumo Glidewire™ guidewire; a Terumo Traxcess™ guidewire; anX-Celerator™ guidewire; an X-Pedion™ guidewire; an Agility™ guidewire; aBentson™ guidewire; a Coon™ guidewire; an Amplatz™ guidewire; andcombinations of one or more of these. In some embodiments, system 10comprises a probe 100 and one or more guidewires 60. Guidewires 60 cancomprise one or more visualizable portions, such as one or moreradiopaque or ultrasonically reflective portions.

System 10 can comprise various sets and configurations of deliverycatheters 50 and guidewires 60. In some embodiments, delivery catheters50 comprise a first delivery catheter 50 _(INTRO) comprising anintroducer (e.g. a vascular introducer), and at least two deliverycatheters 50 that are inserted through delivery catheter 50 _(INTRO),these catheters comprising corresponding different sets of IDs and ODs,such as to allow sequential insertion of each delivery catheter 50through the lumen 52 of a previously placed delivery catheter 50, asdescribed in detail herein. In some embodiments, a first deliverycatheter 50 is advanced over a first guidewire 60, and a smaller ODdelivery catheter 50 is subsequently advanced over a smaller ODguidewire 60 (e.g. after the first guidewire 60 is removed from thefirst delivery catheter 50 and replaced with the second guidewire 60).In some embodiments, after image data is collected by an imaging probe100 positioned within a delivery catheter (e.g. after a retraction inwhich the image data is collected), imaging probe 100 is removed andreplaced with a guidewire 60 over which an additional device can beplaced (e.g. another delivery catheter 50, a treatment device 91, animplant delivery device 80 or other device). In some embodiments, probe100, one or more delivery catheters 50 and/or one or more guidewires 60are inserted, advanced and/or retracted as described herein.

Probe 100, one or more delivery catheters 50 and/or one or moreguidewires 60 can be advanced to a patient site PS through one or moreblood vessels (e.g. advancement of or more delivery catheters 50 over aguidewire 60 through one or more arteries or veins). Alternatively oradditionally, probe 100, one or more delivery catheters 50 and/or one ormore guidewires 60 can be advanced to a patient site PS via a non-bloodvessel lumen, such as the epidural and/or intrathecal space of thespine, or via another body lumen or space (e.g. also as can be performedover a guidewire 60).

In some embodiments, one or more delivery catheters 50 comprise afunctional element 53 (e.g. functional elements 53 a, 53 b, 53 c and 53n shown). Each functional element 53 can comprise one or more functionalelements such as one or more sensors, transducers and/or otherfunctional elements as described in detail herebelow. In someembodiments, shaft 110 comprises a length of at least 100 cm, at least200 cm, at least 240 cm. In some embodiments, shaft 110 comprises alength of approximately 250 cm. In some embodiments, shaft 110 comprisesa length less than or equal to 350 cm, less than or equal to 250 cm, orless than or equal to 220 cm.

In some embodiments, shaft 110 comprises an outer diameter (OD) between0.005″ and 0.022″ along at least a portion of its length (e.g. at leasta portion of distal portion 119 a). In some embodiments, shaft 110comprises an OD of approximately 0.0134″, an OD at or below 0.014″ or anOD at or below 0.016″, along at least a portion of its length (e.g.along a portion surrounding core 120 and/or optical assembly 130, and/oralong at least the most distal 10 cm, 20 cm or 30 cm of shaft 110). Inthese embodiments, imaging probe 100 can be configured to be advancedand/or retracted without a guidewire or delivery catheter (e.g. whenoptical assembly 130 and shaft 110 are retracted in unison duringcollection of image data). In some embodiments, shaft 110 comprises anOD that is less than 1 mm, or less than 500 μm, along at least a portionof its length. In some embodiments, shaft 110 comprises an OD thatchanges along its length. In some embodiments, distal portion 119 acomprises a larger OD than an OD of mid portion 115, such as when theportion of distal portion 119 a surrounding optical assembly 130 has alarger OD than an OD of mid-portion 115. In these embodiments, distalportion 119 a can comprise a larger or similar ID as an ID of midportion 115.

In some embodiments, shaft 110 comprises an inner diameter (ID) between0.004″ and 0.012″, along at least a portion of its length. In someembodiments, shaft 110 comprises an ID of approximately 0.0074″ along atleast a portion of its length (e.g. along a portion surrounding core 120and/or optical assembly 130). In some embodiments, shaft 110 comprisesan ID that changes along its length. In some embodiments, distal portion119 a comprises a larger ID than an ID of mid portion 115, such as whenthe portion of distal portion 119 a surrounding optical assembly 130 hasa larger ID than an ID of mid-portion 115.

In some embodiments, shaft 110 comprises a wall thickness of 0.001″ to0.005″, or a wall thickness of approximately 0.003″, along at least aportion of its length (e.g. along a portion surrounding core 120 and/oroptical assembly 130. In some embodiments, shaft 110 comprises a thinnerwall surrounding at least a portion of optical assembly 130 (e.g.thinner than a portion of the wall surrounding core 120).

In some embodiments, shaft 110 distal portion 119 a has a larger ID thanmid portion 115 of shaft 110, such as when mid portion 115 has an ID atleast 0.002″ larger than the ID of distal portion 119 a. In theseembodiments, the OD of mid portion 115 and the OD of distal portion 119a can be of similar magnitude. Alternatively, the OD of mid portion 115can be different than the OD of distal portion 119 a (e.g. the OD ofdistal portion 119 a can be greater than the OD of mid portion 115, suchas when distal portion 119 a is at least 0.001″ larger).

In some embodiments, imaging probe 100 comprises a stiffened portion,such as when imaging probe 100 comprises stiffening element 118.Stiffening element 118 is positioned in, within and/or along at least aportion of shaft 110. In some embodiments, stiffening element 118 ispositioned within or on the inside surface of the wall of shaft 110. Insome embodiments, stiffening element 118 comprises a wire wound overcore 120. In some embodiments, stiffening element 118 terminatesproximal to optical assembly 130. Alternatively, stiffening element 118can travel lateral to and/or potentially beyond optical assembly 130,such as when the portion of stiffening element 118 comprises one or moreoptically transparent materials.

In some embodiments, distal portion 119 a comprises a wall thicknessthat is less than the wall thickness of mid portion 115. In someembodiments, distal portion 119 a comprises a stiffer material than thematerials of mid portion 115, and/or distal portion 119 a includes astiffening element (e.g. stiffening element 118 a shown in FIG. 13herebelow), such as when distal portion 119 a comprises a wall thicknessless than the wall thickness of mid portion 115.

In some embodiments, probe 100 comprises a guidewire lumen, such as arapid exchange guidewire lumen positioned in a sidecar 105 shown inFIG. 1. Sidecar 105 can comprise a length of less than 150 mm. Sidecar105 can comprise a length of at least 15 mm, such as a length ofapproximately 25 mm.

In some embodiments, proximal portion 111 a of shaft 110 is configuredto be positioned in a service loop. Shaft 110 proximal portion 111 a cancomprise a different construction than mid portion 115 or different thandistal portion 119 a. For example, proximal portion 111 a can comprise alarger OD than mid portion 115 or a thicker wall than mid portion 115.

In some embodiments, shaft 110 comprises an outer shaft and an inner“torque” shaft, which can be shorter than the outer shaft, such as isdescribed herebelow in reference to FIG. 14. In some embodiments, thetorque shaft terminates prior to a portion of probe 100 that enters thepatient.

In some embodiments, system 10 comprises torque tool 320, a tool thatfrictionally engages shaft 110 of probe 100 (e.g. from a lateraldirection at a location along proximal portion 111 a), and allows anoperator to apply torsional force to shaft 110.

Referring additionally to FIG. 1A, a magnified view of distal portion119 a is illustrated, consistent with the present inventive concepts. Alumen 112 extends from proximal end 111 of shaft 110 to distal portion119 a, ending at a location proximal to distal end 119. Positionedwithin lumen 112 is a rotatable optical core, core 120. An opticalassembly, optical assembly 130 is positioned on the distal end of core120. Optical assembly 130 includes lens 131, and a reflecting surface,reflector 132. Optical assembly 130 is positioned within an opticallytranslucent and/or effectively transparent window portion of shaft 110,viewing portion 117. Optical assembly 130 is constructed and arranged tocollect image data through at least a portion of shaft 110. In someembodiments, optical assembly 130 is further constructed and arranged tocollect image data through at least a portion of an additional device,such as at least a portion of a shaft of a delivery catheter 50 (e.g. anoptically transparent portion of a delivery catheter 50, such astransparent segment 57 described herein). In FIG. 1A, optionalcomponents sidecar 105 and stiffening element 118 have been removed forillustrative clarity.

In some embodiments, a fluid 190 is included in lumen 112 (e.g. in thespace not occupied by core 120 and optical assembly 130), such as fluid190 a and fluid 190 b shown in FIG. 1A where fluid 190 b is positionedaround optical assembly 130, and fluid 190 a is positioned around core120 proximal to optical assembly 130. Fluid 190 (e.g. fluid 190 b) cancomprise an optically transparent fluid. In some embodiments, fluid 190a and fluid 190 b comprise similar materials. Alternatively oradditionally, fluid 190 a and fluid 190 b can comprise dissimilarmaterials. In some embodiments, fluid 190 a comprises a more viscousfluid than fluid 190 b. Fluid 190 a and/or 190 b (singly or collectivelyfluid 190) can be constructed and arranged to limit undesired variationsin rotational velocity of core 120 and/or optical assembly 130. In someembodiments, fluid 190 comprises a gel. In some embodiments, fluid 190comprises a non-Newtonian fluid (e.g. a shear-thinning fluid) or otherfluid whose viscosity changes with shear. Alternatively or additionally,fluid 190 can comprise a lubricant (e.g. to provide lubrication betweencore 120 and shaft 110). In some embodiments, fluid 190 comprises ashear-thinning fluid, and core 120 is rotated at a rate above 50 Hz,such as a rate above 100 Hz or 200 Hz. At higher rotation rates, iffluid 190 comprised a high viscosity Newtonian fluid, the resultantviscous drag during rotation of core 120 would result in a torsionalload on core 120 which would cause it to break before the high rotationcould be reached. However, a fluid 190 comprising a low viscosityNewtonian fluid is also not desired, as it would not provide sufficientdampening (e.g. would not provide adequate rotational speed control),such as during low-speed (“idle-mode’) imaging. For these reasons, probe100 can comprise a fluid 190 that is a relatively high viscosity,shear-thinning (non-Newtonian) fluid, that provides sufficient loadingduring low speed rotation of core 120 and, due to its varying viscosity,avoid excessive loading during high speed rotation of core 120. In someembodiments, fluid 190 comprises a shear-thinning fluid whose viscositychanges non-linearly (e.g. its viscosity rapidly decreases withincreasing shear rate). In some embodiments, probe 100 comprises areduced gap between shaft 110 and core 120 along at least a portion ofshaft 110 (e.g. a portion of shaft 110 proximal to optical assembly130), such as via a space reducing element as described herebelow inreference to FIG. 16. This gap can range from 20 μm to 200 μm (e.g. aconstant or varied gap between 20 μm and 200 μm). Fluid 190 (e.g. a highviscosity, shear-thinning fluid) can be positioned (at least) in thereduced gap portion of shaft 110. In this configuration, the amount offorce applied to core 120 to reduce rotational variation is proportionalto the shear stress and the length of shaft 110 in which fluid 190 andshaft 110 interact (the “interaction length”). Positioning of thisinteraction length relatively proximate to optical assembly 130optimizes reduction of undesired rotational velocity variation ofoptical assembly 130 (e.g. since core 120 can have low torsionalrigidity, dampening sufficiently far from optical assembly 130 will notprovide the desired effect upon optical assembly 130).

In some embodiments, optical assembly 130 comprises a lens 131 with anOD that is greater than the diameter of lumen 112 of shaft 110 (e.g.greater than the diameter of at least a portion of lumen 112 that isproximal to optical assembly 130). The OD of lens 131 being greater thanthe diameter of lumen 112 prevents optical assembly 130 from translatingwithin lumen 112. For example, lens 131 can comprise a relatively largediameter aperture lens, such as to provide a small spot size whilecollecting large amounts of light (e.g. a lens 131 with an ODapproaching up to 350 μm). Lumen 112 can be less than this diameter(e.g. less than 350 μm), such as to allow a reduced OD of shaft 110proximal to optical assembly 130 (e.g. as shown in FIGS. 4, 5, 6, 12, 13and 16). In embodiments in which the OD of optical assembly 130 isgreater than the diameter of lumen 112 at locations proximal to opticalassembly 130, the portion of shaft 110 surrounding optical assembly 130has a larger OD and/or ID than the portions of shaft 110 proximal tooptical assembly 130. In these embodiments, both shaft 110 and opticalassembly 130 are retracted simultaneously during collection of imagedata, since lumen 112 has too small a diameter to accommodatetranslation of optical assembly 130.

In some embodiments, fluid 190 (e.g. fluid 190 a) comprises a fluid witha viscosity between 10 Pa-S and 100,000 Pa-S. In these embodiments,fluid 190 can be configured to thin to approximately 3 Pa-S at a shearrate of approximately 100 s⁻¹. In some embodiments, fluid 190 (e.g.fluid 190 b) comprises a viscosity between 1 Pa-S and 100 Pa-S, such asa viscosity of approximately 10 Pa-S. In some embodiments, fluid 190 isconfigured to cause core 120 to tend to remain centered within lumen 112of shaft 110 as it rotates (e.g. due to the shear-thinning nature offluid 190). In some embodiments, fluid 190 a comprises ahydrocarbon-based material and/or silicone. In some embodiments, fluid190 b comprises mineral oil and/or silicone. In some embodiments, probe100 includes one or more fluids 190 in at least the most distal 20 cm ofshaft 110.

In some embodiments, a seal is included in lumen 112, sealing element116, constructed and arranged to provide a seal between core 120 and thewalls of shaft 110 (e.g. when positioned within distal portion 119 a).Sealing element 116 can allow for the rotation of core 120, whilepreventing the mixing and/or migrating of fluids 190 a and/or 190 b(e.g. by resisting the flow of either around seal 116). In someembodiments, a sealing element 116 is positioned between 1 mm and 200from optical assembly 130, such as when sealing element 116 ispositioned approximately 3 mm from optical assembly 130. In someembodiments, sealing element 116 comprises two or more sealing elements,such as two or more sealing elements 116 which slidingly engage core 120and/or optical assembly 130. In some embodiments, probe 100 comprises asealing element positioned in a proximal portion of shaft 110 (e.g.within or proximate connector 102), such as sealing element 151described herebelow in reference to FIG. 7.

Sealing element 116 and/or 151 can comprise an element selected from thegroup consisting of: a hydrogel material; a compliant material;silicone; and combinations of one or more of these. In some embodiments,sealing element 116 and/or 151 can comprise a material bonded to shaft110 with an adhesive, or simply an adhesive itself on shaft 110 (e.g. aUV cured adhesive or an adhesive configured not to bond with core 120).

In some embodiments, fluid 190 is configured to be pressurized, such asis described herein in reference to FIG. 7, such as to reduce bubbleformation and/or bubble growth within fluid 190.

Shaft 110 can comprise one or more materials, and can comprise at leasta portion which is braided and/or includes one or more liners, such as apolyimide or PTFE liner. In some embodiments, at least the distalportion 119 a of shaft 110 comprises an OD less than or equal to 0.025″,such as an OD less than or equal to 0.022″, 0.018″, 0.016″, 0.015″ or0.014″. In some embodiments, shaft 110 comprises a material selectedfrom the group consisting of: polyether ether ketone (PEEK); polyimide;nylon; fluorinated ethylene propylene (FEP); polytetrafluoroethylene(PTFE); polyether block amide (Pebax); and combinations of one or moreof these. In some embodiments, shaft 110 comprises at least a portionincluding a braid including stainless steel and/or a nickel titaniumalloy, such as a shaft 110 including a braid positioned over thin walledFEP or PTF. The braided portion can be coated with Pebax or otherflexible material. In some embodiments, shaft 110 comprises at least aportion (e.g. a proximal portion) that is metal, such as a metalhypotube comprising stainless steel and/or nickel titanium alloy. Insome embodiments, shaft 110 comprises a first portion that is a metaltube, and a second portion, distal to the first portion, that comprisesa braided shaft. In some embodiments, shaft 110 comprises at least aportion that comprises a hydrophobic material or other materialconfigured to reduce changes (e.g. changes in length) when exposed to afluid.

Viewing portion 117 of shaft 110 can comprise one or more materials, andcan comprise similar or dissimilar materials to a different portion ofshaft 110. Viewing portion 117 can comprise a similar ID and/or OD asone or more other portions of shaft 110. In some embodiments, viewingportion 117 comprises an ID and/or OD that is larger than an ID and/orOD of shaft 110 at mid portion 115 of shaft 110. Viewing portion 117 cancomprise a similar or dissimilar flexibility as one or more otherportions of shaft 110. Viewing portion 117 can comprise one or moreoptically transparent materials selected from the group consisting of:Pebax; Pebax 7233; PEEK; amorphous PEEK; polyimide; glass; sapphire;nylon 12; nylon 66; and combinations of one or more of these.

In some embodiments, a flexible tip portion is positioned on the distalend of shaft 110, such as spring tip 104 shown. Spring tip 104 cancomprise a length of between 0.5 cm and 5 cm, such as a length ofapproximately lcm, 2 cm or 3 cm, or a length between 2 cm and 3 cm. Atleast a portion of spring tip 104 can be made visible to an imagingapparatus, such as by including a radiopaque material such as platinumor other material visible to an X-ray imaging device. Spring tip 104 cancomprise a core comprising a material such as stainless steel.

In some embodiments, probe 100 and/or other components of system 10comprise one or more markers (e.g. radiopaque or other visualizablemarkers), sensors, transducers or other functional elements such as:functional elements 53 a-n of delivery catheters 50; functional element83 of implant delivery device 80; functional element 93 of treatmentdevice 91; functional elements 113 a and 113 b (singly or collectivelyfunctional element 113, described herebelow) of shaft 110; functionalelement 123 of core 120; functional element 133 of optical assembly 130;functional element 203 of console 200; and functional element 303 ofinjector 300.

In some embodiments, core 120 comprises a single mode glass fiber, suchas a fiber with an OD between 40 μm and 175 μm, a fiber with an ODbetween 80 μm and 125 μm, a fiber with an OD between 60 μm and 175 μm,or a fiber with an OD of approximately 110 μm. Core 120 can comprise amaterial selected from the group consisting of: silica glass; plastic;polycarbonate; and combinations of one or more of these. Core 120 cancomprise a fiber with a coating, such as a polyimide coating. Core 120can comprise cladding material and/or coatings surrounding the fiber,such as are known to those of skill in the art. Core 120 can comprise anumerical aperture (NA) of at or above 0.11, such as an NA ofapproximately 0.16 or 0.20. In some embodiments, core 120 can comprisean NA (e.g. an NDA between 0.16 and 0.20) to significantly reducebend-induced losses, such as would be encountered in tortuous anatomy.System 10 can be configured to rotate core 120 in a single direction(uni-directional rotation) or multi-directional (bi-directionalrotation).

In some embodiments, probe 100 and other components of system 10 areconfigured to retract core 120 within shaft 110. In these embodiments,probe 100 can be configured such that a material (e.g. fluid 190) isintroduced into and within shaft 110 (e.g. between core 120 and shaft110). The introduced material can be configured to provide a functionselected from the group consisting of: index matching; lubrication;purging of bubbles; and combinations of one or more of these.

In some embodiments, optical assembly 130 comprises an OD between 80 μmand 500 μm, such as an OD of at least 125 μm, or an OD of approximately150 μm. In some embodiments, optical assembly 130 comprises a length ofbetween 200 μm and 3000 μm, such as a length of approximately 1000 μm.Optical assembly 130 can comprise one or more lenses, such as lens 131shown, such as a GRIN lens and/or a ball lens. Optical assembly 130 cancomprise a GRIN lens with a focal length between 0.5 mm and 10.0 mm,such as approximately 2.0 mm. Optical assembly 130 can comprise one ormore reflecting elements, such as reflecting element 132 shown.

In some embodiments, optical assembly 130 comprises a lens 131 and areflecting element 132 which is positioned offset from lens 131 via oneor more connecting elements 137 as shown in FIG. 18. Connecting element137 can comprise a tube (e.g. a heat shrink tube) surrounding at least aportion of lens 131 and reflecting element 132. Connecting element 137can comprise one or more elements selected from the group consisting of:tube; flexible tube; heat shrink; optically transparent arm; andcombinations of one or more of these. Connecting element 137 canposition reflecting element 132 at a distance of between 0.01 mm and 3.0mm from lens 131, such as at a distance between 0.01 mm and 1.0 mm.Reflecting element 132 can comprise a partial portion of a largerassembly that is cut or otherwise separated (e.g. cleaved) from thelarger assembly during a manufacturing process used to fabricate opticalassembly 130. Use of the larger assembly can simplify handling duringmanufacturing. In some embodiments, the resultant reflecting element 132comprises a shape-optimized reflector. Reflecting element 132 cancomprise a segment of wire, such as a gold wire. In these embodiments,lens 131 can comprise a GRIN lens, such as a lens with an OD ofapproximately 150 μm and/or a length of approximately 1000 μm. In someembodiments, lens 131 further comprises a second lens, such as acoreless lens positioned proximal to and optically connected to the GRINlens.

In some embodiments, imaging probe 100 comprises a reduced diameterportion (e.g. a reduced outer and/or inner diameter portion) along shaft110, at a location proximal to optical assembly 130, such as is shown inFIGS. 4, 5, 6, 12, 13 and 16. In these embodiments, optical assembly 130can comprise an OD that is larger than lumen 112 of shaft 110 (e.g. at alocation proximal to optical assembly 130), such as to provide a largerlens 131 for improved imaging capability. In some embodiments, probe 100comprises a space reducing element between shaft 110 and core 120, suchas is described herebelow in reference to elements 122 of FIG. 16.Functional elements 113 and/or 123 can comprise a space reducing element(e.g. a projection from shaft 110 and/or core 120, respectively).

Console 200 can comprise an assembly, rotation assembly 210 constructedand arranged to rotate at least core 120. Rotation assembly 210 cancomprise one or more motors configured to provide the rotation, such asa motor selected from the group consisting of: DC motor; AC motor;stepper motor; synchronous motor; and combinations of one or more ofthese. Console 200 can comprise an assembly, retraction assembly 220,constructed and arranged to retract at least shaft 110. Retractionassembly 220 can comprise one or more motors or linear drive elementsconfigured to provide the retraction, such as a component selected fromthe group consisting of: DC motor; AC motor; stepper motor; synchronousmotor; gear mechanism, linear drive mechanism; magnetic drive mechanism;piston; pneumatic drive mechanism; hydraulic drive mechanism; andcombinations of one or more of these. Rotation assembly 210 and/orretraction assembly 220 can be of similar construction and arrangementto those described in applicant's co-pending application U.S.Provisional Application Ser. No. 62/148,355, titled “Micro-Optic Probesfor Neurology”, filed Apr. 29, 2015; the content of which isincorporated herein by reference in its entirety for all purposes.

Console 200 can comprise an imaging assembly 230 configured to providelight to optical assembly 130 (e.g. via core 120) and collect light fromoptical assembly 130 (e.g. via core 120). Imaging assembly 230 caninclude a light source 231. Light source 231 can comprise one or morelight sources, such as one or more light sources configured to provideone or more wavelengths of light to optical assembly 130 via core 120.Light source 231 is configured to provide light to optical assembly 130(via core 120) such that image data can be collected comprisingcross-sectional, longitudinal and/or volumetric information related tothe patient site PS or implanted device being imaged. Light source 231can be configured to provide light such that the image data collectedincludes characteristics of tissue within the patient site PS beingimaged, such as to quantify, qualify or otherwise provide informationrelated to a patient disease or disorder present within the patient sitePS being imaged. Light source 231 can be configured to deliver broadbandlight and have a center wavelength in the range from 800 nm to 1700 nm.The light source 231 bandwidth can be selected to achieve a desiredresolution, which can vary according to the needs of the intended use ofsystem 10. In some embodiments, bandwidths are about 5% to 15% of thecenter wavelength, which allows resolutions of between 20 μm and 5 μm,respectively. Light source 231 can be configured to deliver light at apower level meeting ANSI Class 1 (“eye safe”) limits, though higherpower levels can be employed. In some embodiments, light source 231delivers light in the 1.3 μm band at a power level of approximately 20mW. Tissue light scattering is reduced as the center wavelength ofdelivered light increases, however water absorption also increases.Light source 231 can deliver light at a wavelength approximating 1300 nmto balance these two effects. Light source 231 can be configured todeliver shorter wavelength light (e.g. approximately 800 nm light) totraverse patient sites to be imaged including large amounts of fluid.Alternatively or additionally, light source 231 can be configured todeliver longer wavelengths of light (e.g. approximately 1700 nm light),such as to reduce a high level of scattering within a patient site to beimaged.

Imaging assembly 230 (or another component of console 200) can comprisea fiber optic rotary joint (FORJ) configured to transmit light fromlight source 231 to core 120, and to receive light from core 120. Insome embodiments, core 120 comprises a fiber with a first numericalaperture (NA), and imaging assembly 230 comprises an imaging assemblyoptical core with a second NA different than the first NA. For example,the first NA (the NA of of core 120) can comprise an NA of approximately0.16 and the second NA (the NA of the imaging assembly optical core) cancomprise an NA of approximately 0.11. In some embodiments, system 10comprises an adaptor 310 configured to optically connect probe 100 toimaging assembly 230 (e.g. a single use or limited use disposableadaptor used in less procedures than imaging assembly 230). Adaptor 310can comprise a lens assembly configured to “optically match” (e.g. tominimize coupling losses) different numerical apertures (such as thefirst and second NAs described hereabove). In some embodiments, adaptor310 comprises a fiber with an NA that is the geometric mean of the twodifferent NAs. In some embodiments, adaptor 310 comprises a fiber withan NA that is the arithmetic mean of the two different NAs.

Rotation assembly 210 can be constructed and arranged to rotate core 120(and subsequently one or more components of optical assembly 130), at arotational velocity of approximately 250 rps, or at a rotationalvelocity between 40 rps and 1000 rps. Rotation assembly 210 can beconfigured to rotate core 120 at a rate between 20 rps and 2500 rps. Insome embodiments, rotation assembly 210 can be configured to rotate core120 at a rate up to 25,000 rps. In some embodiments, the rotation rateprovided by rotation assembly 210 is variable, such as when the rotationrate is varied based on a signal provided by a sensor of system 10, suchas when one or more of functional elements 53, 83, 93, 113, 123, 133,203 and/or 303 comprise a sensor, and algorithm 240 is used to analyzeone or more signals from the one or more sensors. In some embodiments,the sensor signal represents the amount of light collected from tissueor other target. In some embodiments, system 10 is configured to varythe rotation rate provided by rotation assembly 210 when the sensorsignal correlates to a parameter selected from the group consisting of:tortuosity of vessel in which probe 100 is placed; narrowing of vesselin which probe 100 is placed; presence of clot proximate opticalassembly 130; presence of an implanted device proximate optical assembly130; and combinations thereof. In some embodiments, the rotation rateprovided by rotation assembly 210 is varied by an operator of system 10(e.g. a clinician). Alternatively or additionally, system 10 can varythe rotation rate provided by rotation assembly 210 automatically or atleast semi-automatically (“automatically” herein), such as an automaticvariation of a rotation rate as determined by one or more signals fromone or more sensors as described hereabove. In some embodiments,rotation by rotation assembly 210 is increased (manually orautomatically) when optical assembly 130 is collecting image data from atarget area.

In some embodiments, rotation assembly 210 is constructed and arrangedto rotate core 120 at one rate (e.g. at least 150 rps or approximately250 rps) during image data collection (i.e. an “imaging mode”), and at adifferent rate (e.g. a slower rate, such as a rate between 30 rps and150 rps), during a “preview mode”. During preview mode, a “positioningoperation” can be performed in which optical assembly 130 is linearlypositioned and/or a flush procedure can be initiated. The positioningoperation can be configured to visualize bright reflections (e.g. viaone or more implants such as an implanted stent, flow director and/orcoils). Alternatively or additionally, the preview mode can beconfigured to allow an operator (e.g. a clinician) to confirm thatoptical assembly 130 has exited the distal end 59 of a surroundingdelivery catheter 50. The preview mode can be configured to reduce timeand acceleration forces associated with rotating core 120 at a velocityto accommodate image data collection (e.g. a rotational velocity of atleast 150 rps or approximately 250 rps).

Retraction assembly 220 can be constructed and arranged to retractoptical assembly 130 (e.g. by core 120 and/or retracting shaft 100) at aretraction rate of approximately 40 mm/sec, such as a retraction ratebetween 3 mm/sec and 500 mm/sec (e.g. between 5 mm/sec and 60 mm/sec, orapproximately 50 mm/sec). Retraction assembly 220 can be constructed andarranged to perform a pullback of between 20 mm and 150 mm (e.g. apullback of approximately 50 mm or 75 mm), such as a pullback that isperformed in a time period between 0.1 seconds and 15.0 seconds, such asa period between 0.1 and 10 seconds, or a period of approximately 4seconds. In some embodiments, pullback distance and/or pullback rate areoperator selectable and/or variable (e.g. manually or automatically). Insome embodiments, the pullback distance and/or pullback rate provided byretraction assembly 220 is variable, such as when the pullback distanceand/or pullback rate is varied based on a signal provided by a sensor ofsystem 10, such as when one or more of functional elements 53, 83, 93,113, 133, 203 and/or 303 comprise a sensor, and algorithm 240 is used toanalyze one or more signals from the one or more sensors. In someembodiments, the sensor signal represents the amount of light collectedfrom tissue or other target. In some embodiments, system 10 isconfigured to vary the pullback distance and/or pullback rate providedby retraction assembly 220 when the sensor signal correlates to aparameter selected from the group consisting of: tortuosity of vessel inwhich probe 100 is placed; narrowing of vessel in which probe 100 isplaced; presence of clot proximate optical assembly 130; presence of animplanted device proximate optical assembly 130; and combinationsthereof. In some embodiments, the pullback distance and/or pullback rateprovided by retraction assembly 220 is varied by an operator of system10 (e.g. a clinician). Alternatively or additionally, system 10 can varythe pullback distance and/or pullback rate provided by retractionassembly 210 automatically or at least semi-automatically(“automatically” herein), such as an automatic variation of a pullbackdistance and/or pullback rate as determined by one or more signals fromone or more sensors as described hereabove. In some embodiments,pullback distance and/or pullback rate by retraction assembly 220 isvaried (increased or decreased, manually or automatically) when opticalassembly 130 is collecting image data from a target area.

In some embodiments, retraction assembly 220 and probe 100 areconfigured such that during image data collection, retraction assembly220 retracts core 120 without causing translation to shaft 110 (e.g.core 120 retracts within lumen 112 of shaft 110).

In some embodiments, retraction assembly 220 and probe 100 can beconfigured such that during image data collection, retraction assembly220 retracts core 120 and shaft 110 in unison. In these embodiments,shaft 110 can comprise a relatively short viewing window, viewingportion 117 surrounding optical assembly 130, since optical assembly 130does not translate within shaft 110. For example, in these embodiments,viewing portion 117 can comprise a length less than or equal to 20 mm,less than or equal to 15 mm, less than or equal to 6 mm, or less than orequal to 4 mm, such as when viewing portion 117 comprises a length ofapproximately 3 mm. In some embodiments, viewing portion 117 comprises alength between 5 mm and 50 mm, such as a length of approximately 10 mmor approximately 12 mm. In these embodiments in which optical assembly130 does not translate within shaft 110, shaft 110 diameter (ID and/orOD) can be reduced at locations proximal to viewing portion 117, such aswhen the OD of shaft 110 (at least the portion of shaft 110 surroundingand proximate optical assembly), comprises a diameter of less than orequal to 0.025″, 0.016″ or 0.014″. Alternatively or additionally, inthese embodiments in which optical assembly 130 does not translatewithin shaft 110, portions of the shaft proximal to optical assembly 130(e.g. proximal to viewing portion 117) can include a non-transparentconstruction, such as a braided construction or a construction usingmaterials such as metal tubing (e.g. nitinol or stainless steelhypotube), such as to improve pushability of probe 100.

Retraction assembly 220 can be configured to minimize formation ofbubbles within any fluid (e.g. fluid 190) within shaft 110, such as byretracting shaft 110 and core 120 in unison, or by retracting core 120at a precision rate to avoid bubble formation. When shaft 110 isretracted, proximal portion 111 a can be configured to be positioned ina service loop. Retraction assembly 220 can comprise a translatableslide, and rotation assembly 210 can be positioned on the translatableslide.

Retraction assembly 220 can comprise a telescoping retraction assembly.Retraction assembly 220 can comprise a motor, such as a single use orotherwise sometimes disposable motor, such as a disposable motor that ispart of a telescoping retraction assembly.

In some embodiments, rotation assembly 210 can be independentlypositioned in reference to retraction assembly 220. In some embodiments,retraction assembly 220 is configured to be positioned closer to thepatient than the rotation assembly 210 is positioned (e.g. whenretraction assembly 220 is positioned within 20 cm of a vascularintroducer or other patient introduction device through which probe 100is inserted). In some embodiments, retraction assembly 220 is configuredto removably attach to a patient introduction device, such as to connectto a Touhy connector of a vascular introducer through which probe 100 isinserted, such as a delivery catheter 50 described herein.

In some embodiments, retraction assembly 220 receives “motive force”from console 200, such as via drive shaft 211 that may be operablyattached to rotation assembly 210 as shown in FIG. 1.

Console 200 can comprise a display 250, such as a display configured toprovide one or more images (e.g. video) based on the collected imagedata. Imaging assembly 230 can be configured to provide an image ondisplay 250 with an updated frame rate of up to approximately 250 framesper second (e.g. similar to the rotational velocity of core 120).Display 250 can provide a 2-D and/or 3-D representation of 2-D and/or3-D data.

Console 200 can comprise one or more functional elements, such asfunctional element 203 shown in FIG. 1. Functional element 203 cancomprise one or more functional elements such as one or more sensors,transducers and/or other functional elements as described in detailherebelow.

Console 200 can comprise an algorithm, such as algorithm 240 shown,which can be configured to adjust (e.g. automatically and/orsemi-automatically adjust) one or more operational parameters of system10, such as an operational parameter of console 200, probe 100 and/or adelivery catheter 50. Alternatively or additionally, algorithm 240 canbe configured to adjust an operational parameter of a separate device,such as injector 300 or implant delivery device 80 described herebelow.In some embodiments, algorithm 240 is configured to adjust anoperational parameter based on one or more sensor signals, such as asensor signal provided by a sensor-based functional element of thepresent inventive concepts as described herein (e.g. a signal providedby one or more of functional elements 53, 83, 93, 113, 123, 203 and/or303). Algorithm 240 can be configured to adjust an operational parameterselected from the group consisting of: a rotational parameter such asrotational velocity of core 120 and/or optical assembly 130; aretraction parameter of shaft 110 and/or optical assembly 130 such asretraction velocity, distance, start position, end position and/orretraction initiation timing (e.g. when retraction is initiated); aposition parameter such as position of optical assembly 130; a linespacing parameter such as lines per frame; an image display parametersuch as a scaling of display size to vessel diameter; a probe 100configuration parameter; an injectate 305 parameter such as a saline tocontrast ratio configured to determine an appropriate index ofrefraction; a light source 231 parameter such as power delivered and/orfrequency of light delivered; and combinations of one or more of these.In some embodiments, algorithm 240 is configured to adjust a retractionparameter such as a parameter triggering the initiation of the pullback,such as a pullback that is initiated based on a parameter selected fromthe group consisting of: lumen clearing; injector 300 signal; change inimage data collected (e.g. a change in an image, based on the image datacollected, that correlates to proper evacuation of blood from aroundoptical assembly 130); and combinations of one or more of these. In someembodiments, algorithm 240 is configured to adjust a probe 100configuration parameter, such as when algorithm 240 identifies (e.g.automatically identifies via an RF or other embedded ID) the attachedprobe 100 and adjusts a parameter such as arm path length and/or otherparameter as listed above.

Injector 300 can comprise a power injector, syringe pump, peristalticpump or other fluid delivery device configured to inject a contrastagent, such as radiopaque contrast, and/or other fluids. In someembodiments, injector 300 is configured to deliver contrast and/or otherfluid (e.g. contrast, saline and/or Dextran). In some embodiments,injector 300 delivers fluid in a flushing procedure as describedherebelow. In some embodiments, injector 300 delivers contrast or otherfluid through a delivery catheter 50 with an ID of between 5 Fr and 9Fr, a delivery catheter 50 with an ID of between 0.53″ to 0.70″, or adelivery catheter 50 with an ID between 0.0165″ and 0.027″. In someembodiments, contrast or other fluid is delivered through a deliverycatheter as small as 4 Fr (e.g. for distal injections). In someembodiments, injector 300 delivers contrast and/or other fluid throughthe lumen of one or more delivery catheters 50, while one or moresmaller delivery catheters 50 also reside within the lumen 52. In someembodiments, injector 300 is configured to deliver two dissimilar fluidssimultaneously and/or sequentially, such as a first fluid delivered froma first reservoir and comprising a first concentration of contrast, anda second fluid from a second reservoir and comprising less or nocontrast. Injector 300 can comprise one or more functional elements,such as functional element 303 shown in FIG. 1. Functional element 303can comprise one or more functional elements such as one or moresensors, transducers and/or other functional elements as described indetail herebelow.

Implant 85 can comprise an implant (e.g. a temporary or chronic implant)for treating one or more of a vascular occlusion or an aneurysm. In someembodiments, implant 85 comprises one or more implants selected from thegroup consisting of: a flow diverter; a Pipeline™ flow diverter; aSurpass™ flow diverter; an embolization coil; a stent; a Wingspan™stent; a covered stent; an aneurysm treatment implant; and combinationsof one or more of these. Delivery device 80 can comprise a catheter orother tool used to deliver implant 85, such as when implant 85 comprisesa self-expanding or balloon expandable portion. Implant delivery device80 can comprise a functional element, such as functional element 83shown in FIG. 1. Functional element 83 can comprise one or morefunctional elements such as one or more sensors, transducers and/orother functional elements as described in detail herebelow. In someembodiments, system 10 comprises a probe 100, one or more implants 85and/or one or more implant delivery devices 80, such as is described inapplicant's co-pending application U.S. Provisional Application Ser. No.62/212,173, titled “Imaging System includes Imaging Probe and DeliveryDevices”, filed Aug. 31, 2015; the content of which is incorporatedherein by reference in its entirety for all purposes. In someembodiments, probe 100 is configured to collect data related to implant85 and/or implant delivery device 80 (e.g. implant 85 and/or implantdelivery device 80 anatomical location, orientation and/or otherconfiguration data), after implant 85 and/or implant delivery device 80has been inserted into the patient.

Treatment device 91 can comprise an occlusion treatment or othertreatment device selected from the group consisting of: a ballooncatheter constructed and arranged to dilate a stenosis or othernarrowing of a blood vessel; a drug eluting balloon; an aspirationcatheter; a sonolysis device; an atherectomy device; a thrombus removaldevice such as a stent retriever device; a Trevo™ stentriever; aSolitaire™ stentriever; a Revive™ stentriever; an Eric™ stentriever; aLazarus™ stentriever; a stent delivery catheter; a microbraid implant;an embolization system; a WEB™ embolization system; a Luna™ embolizationsystem; a Medina™ embolization system; and combinations of one or moreof these. In some embodiments, treatment device 91 comprises atherapeutic device selected from the group consisting of: stentretriever; embolization coil; embolization coil delivery catheter;stent; covered stent; stent delivery device; aneurysm treatment implant;aneurysm treatment implant delivery device; flow diverter; ballooncatheter; and combinations thereof. In some embodiments, probe 100 isconfigured to collect data related to treatment device 91 (e.g.treatment device 91 location, orientation and/or other configurationdata), after treatment device 91 has been inserted into the patient.Treatment device 91 can comprise a functional element, such asfunctional element 93 shown in FIG. 1.

2^(nd) Imaging device 92 can comprise an imaging device such as one ormore imaging devices selected from the group consisting of: an X-ray; afluoroscope such as a single plane or biplane fluoroscope; a CT Scanner;an MM; a PET Scanner; an ultrasound imager; and combinations of one ormore of these.

Functional elements 53, 83, 93, 113, 123, 133, 203, and/or 303 can eachcomprise one or more sensors, transducers and/or other functionalelements, as described in detail herebelow.

In some embodiments, a functional element 113 is positioned proximateoptical assembly 130 (e.g. functional element 113 b positioned distal tooptical assembly 130 as shown in FIG. 1A, at the same axial location asoptical assembly 130 and/or proximal to optical assembly 130). In someembodiments, imaging probe 100 comprises functional element 113 a shownin FIG. 1. Functional element 113 a is shown positioned on a proximalportion of shaft 110, however it can be positioned at another probe 100location such as on, in and/or within connector 102. Functional elements113 a and/or 113 b (singly or collectively functional element 113) caneach comprise one or more functional elements such as one or moresensors, transducers and/or other functional elements as described indetail herebelow.

In some embodiments, functional element 53, 83, 93, 113, 123, 133, 203and/or 303 comprise a sensor, such as a sensor configured to provide asignal related to a parameter of a system 10 component and/or a sensorconfigured to provide a signal related to a patient parameter.Functional element 53, 83, 93, 113, 123, 133, 203 and/or 303 cancomprise one or more sensors selected from the group consisting of: aphysiologic sensor; a pressure sensor; a strain gauge; a positionsensor; a GPS sensor; an accelerometer; a temperature sensor; a magneticsensor; a chemical sensor; a biochemical sensor; a protein sensor; aflow sensor such as an ultrasonic flow sensor; a gas detecting sensorsuch as an ultrasonic bubble detector; a sound sensor such as anultrasound sensor; and combinations of one or more of these. In someembodiments, functional element 53, 83, 93, 113, 123, 133, 203 and/or303 can comprise one or more physiologic sensors selected from the groupconsisting of: a pressure sensor such as a blood pressure sensor; ablood gas sensor; a flow sensor such as a blood flow sensor; atemperature sensor such as a blood or other tissue temperature sensor;and combinations of one or more of these. In some embodiments, algorithm240 is configured to process the signal received by a sensor, such as asignal provided by a sensor as described herein. In some embodiments,functional element 53, 83, 93, 113, 123 and/or 133 comprises a positionsensor configured to provide a signal related to a vessel path (e.g. avessel lumen path) in three dimensions. In some embodiments, functionalelement 53, 83, 93, 113, 123 and/or 133 comprises a magnetic sensorconfigured to provide a signal for positioning optical assembly 130relative to one or more implanted devices (e.g. one or more implants 85described herein comprising a ferrous or other magnetic portion). Insome embodiments, functional element 53, 83, 93, 113, 123 and/or 133comprises a flow sensor, such as a flow sensor configured to provide asignal related to blood flow through a blood vessel of the patient sitePS (e.g. blood flow through a stenosis or other partially occludedsegment of a blood vessel). In these embodiments, algorithm 240 can beconfigured to assess blood flow (e.g. assess the significance of anocclusion), such as to provide information to a clinician regardingpotential treatment of the occlusion. In some embodiments, opticalassembly 130 comprises functional element 113, such as when opticalassembly 130 is constructed and arranged as a sensor that provides asignal related to blood flow. In some embodiments, functional element53, 83, 93, 113, 123 and/or 133 comprises a flow sensor configured toprovide a signal used to co-register vessel anatomic data to flow data,which can be used to provide pre and post intervention modeling of flow(e.g. aneurysm flow), assess risk of rupture and/or otherwise assessadequacy of the intervention. In some embodiments, functional element53, 83, 93, 113, 123 and/or 133 comprises an ultrasound sensorconfigured to provide a signal (e.g. image or frequency data) which canbe co-registered with near field optical derived information provided byoptical assembly 130. In some embodiments, functional element 53, 83, 93and/or 113 are configured to be deployed by their associated device,such as to implant the functional element (e.g. a sensor-basedfunctional element) into the patient. The implantable functional element53, 83, 93 and/or 113 can comprise microchip and/or MEMS components. Theimplantable functional element 53, 83, 93 and/or 113 can comprise atleast a portion that is configured to be visualized (e.g. by image datacollected by probe 100 and/or a separate imaging device such as secondimaging device 92.

In some embodiments, functional element 53, 83, 93, 113, 123, 133, 203and/or 303 comprise one or more transducers selected from the groupconsisting of: a heating element such as a heating element configured todeliver sufficient heat to ablate tissue; a cooling element such as acooling element configured to deliver cryogenic energy to ablate tissue;a sound transducer such as an ultrasound transducer; a vibrationaltransducer; and combinations of one or more of these.

In some embodiments, functional element 53, 83, 93 and/or 113 comprisesa pressure release valve configured to prevent excessive pressure fromaccumulating in the associated device. In some embodiments, functionalelement 53, 83, 93 and/or 113 comprises one or more sideholes, such asone or more sideholes used to deliver a fluid in a flushing procedure asdescribed herein.

In some embodiments, functional element 53, 83, 93, 113, 123, 133, 203and/or 303 comprise a visualizable marker, such as when functionalelement 53, 83, 93 and/or 113 comprise a marker selected from the groupconsisting of: radiopaque marker; ultrasonically reflective marker;magnetic marker; ferrous material; and combinations of one or more ofthese.

Probe 100 is configured to collect image data, such as image datacollected during rotation and/or retraction of optical assembly 130.Optical assembly 130 can be rotated by rotating core 120. Opticalassembly 130 can be retracted by retracting shaft 110. Optical assembly130 can collect image data while surrounded by a portion of a shaft of adelivery catheter 50 (e.g. when within a transparent segment 57 of adelivery catheter) and/or when there is no catheter 50 segmentsurrounding optical assembly 130 (e.g. when optical assembly 130 hasbeen advanced beyond the distal ends 59 of all delivery catheters 50into which probe 100 is inserted).

During collection of image data, a flushing procedure can be performed,such as by delivering one or more fluids, injectate 305 (e.g. aspropelled by injector 300 or other fluid delivery device), to removeblood or other somewhat opaque material (hereinafter non-transparentmaterial) proximate optical assembly 130 (e.g. to remove non-transparentmaterial between optical assembly 130 and a delivery catheter and/ornon-transparent material between optical assembly 130 and a vesselwall), such as to allow light distributed from optical assembly 130 toreach and reflectively return from all tissue and other objects to beimaged. In these flushing embodiments, injectate 305 can comprise anoptically transparent material, such as saline. Injectate 305 cancomprise one or more visualizable materials, as described herebelow.Injectate 305 can be delivered by injector 300 as described hereabove.

Flush rates required for providing clearance around optical assembly 130can scale inversely with the viscosity of the flush medium. Thismathematical relationship can be driven by the downstream draining ofthe flush medium in the capillary bed. If the capillary bed drainsslowly, it is easier to maintain the upstream flush at a pressure at orslightly above native blood pressure, such that fresh blood will notenter the vessel being imaged (e.g. at a location proximate opticalassembly 130). Conversely, if the capillary bed drains rapidly, theflush rate will need to increase correspondingly. Since saline (astandard flush medium) has a viscosity about ⅓ that of blood (e.g. 1 Cpvs 3.3 Cp), roughly three times normal flow rate will be required toclear a vessel (in the area proximate optical assembly 130), and suchflow rates can pose a risk to vessel integrity. As an alternative,contrast media (e.g. radiopaque contrast media) can be used forflushing. Contrast material has a high viscosity (due to its high iodineconcentrations, typically a concentration of approximately 300 mg/ml).System 10 can comprise a flushing fluid comprising contrast, such ascontrast with a concentration between 50 mg/ml to 500 mg/ml of iodine(e.g. correlating to viscosities approximately two to five times that ofblood). System 10 can comprise a flushing fluid (e.g. a radiopaque orother visualizable flushing fluid) with a viscosity between 1.0 Cp and20 Cp (e.g. at a temperature of approximately 37° C.).

Alternative or in addition to its use in a flushing procedure, injectate305 can comprise material configured to be viewed by second imagingdevice 92, such as when injectate 305 comprise a contrast materialconfigured to be viewed by a second imaging device 92 comprising afluoroscope or other X-ray device; an ultrasonically reflective materialconfigured to be viewed by a second imaging device 92 comprising anultrasound imager; and/or a magnetic material configured to be viewed bya second imaging device 92 comprising an MRI.

Injectate 305 can be delivered by one or more delivery catheters 50(e.g. in the space between a first delivery catheter 50 and an inserteddelivery catheter 50, or in the space between a delivery catheter 50 andan inserted probe 100). Injectate 305 delivered in a flushing procedure(or other injectate 305 delivery procedure) can be delivered out thedistal end 59 of a delivery catheter 50 (e.g. a distal end 59 positionedproximal to optical assembly 130), such as is described in applicant'sco-pending U.S. Provisional Application Ser. No. 62/212,173, titled“Imaging System includes Imaging Probe and Delivery Devices”, filed Aug.31, 2015, the content of which is incorporated herein by reference inits entirety for all purposes. Alternatively or additionally, anydelivery catheter 50 can comprise one or more sideholes passing througha portion of the associated shaft 51, such as sideholes 58 shownpositioned on a distal portion of delivery catheter 50 c. In someembodiments, a delivery catheter 50 comprises a microcatheter comprisingsideholes 58 positioned on a distal portion, such as a microcatheterwith an ID less than 0.027″ (e.g. a microcatheter with an ID between0.016″ and 0.027″ or an ID between 0.021″ and 0.027″). In someembodiments, flushing fluid is delivered towards optical assembly 130from both sideholes 58 and from the distal end 59 of a delivery catheter50. Sideholes 58 can be constructed and arranged to allow a flushingfluid to pass from within shaft 51 and through the sideholes 58, such aswhen a separate shaft is inserted within the delivery catheter 50 (e.g.a shaft 51 of an additional delivery catheter 50 or the shaft 110 ofprobe 100). Delivery of flushing fluid through sideholes 58 and/or thedistal end of the delivery catheter 50 can be performed to clear bloodfrom an area from a luminal segment surrounding optical assembly 130,such as during collecting of image data.

In some embodiments, the delivery of injectate 305 during a flushingprocedure is based on a parameter selected from the group consisting of:a pre-determined volume of injectate to be delivered; a pre-determinedtime during which injectate is delivered; an amount of time of deliveryincluding a time extending from a time prior to retraction of shaft 110that continued until the collecting of the image data has been completed(e.g. completion of retraction of shaft 110); and combinations of one ormore of these. In some embodiments, injector 300 delivers fluid in aflushing procedure with an approximate flow profile selected from thegroup consisting of: contrast (e.g. between 20% and 100% contrast thatcan be mixed with saline) at 5 ml/second for 6 seconds (e.g. for imagingof a carotid artery including 4 seconds of collecting image data);contrast (e.g. between 20% and 100% contrast that can be mixed withsaline) at 4 ml/second for 6 seconds (e.g. for imaging of a vertebralartery including 4 seconds of collecting image data); and combinationsof one or more of these. In some embodiments, a flushing procedurecomprises delivery of injectate 305 (e.g. via one or more deliverycatheters 50) for between 2 seconds to 8 seconds, such as a delivery ofinjectate for approximately 4 seconds (e.g. to purge blood or othernon-transparent fluid from a luminal segment of a blood vessel or otherarea surrounding optical assembly 130 during collection of image datafrom a patient site PS). In similar flushing procedures, injectate 305can be delivered at a rate between 3 ml/second and 9 ml/second (e.g.approximately 6 ml/sec via one or more delivery catheters 50), to purgenon-transparent material.

In these flushing procedures, injectate 305 can comprise a transparentfluid selected from the group consisting of: saline; contrast; Dextran;and combinations of one or more of these. In some embodiments, thevolume of injectate 305 delivered and/or the time of injectate 305delivery during a flushing procedure is determined by a parameterselected from the group consisting of: type of procedure beingperformed; diameter of vessel in which optical assembly 130 ispositioned; length of pullback; duration of pullback; and combinationsof one or more of these. In some embodiments, injectate 305 is deliveredduring a flushing procedure by a delivery catheter with an ID greaterthan 0.027″ (e.g. a first delivery catheter 50 whose distal end 59 ismore proximal than a second delivery catheter 50 inserted into the firstdelivery catheter 50). In some embodiments, injectate 305 is deliveredvia multiple lumens 52 in associated multiple delivery catheters 50(e.g. in the space between two or more pairs of delivery catheters 50arranged to slidingly receive each other in a sequential fashion).

In some embodiments, injectate comprises a first fluid delivered in afirst portion of a flushing procedure (e.g. a fluid comprising salineand/or a fluid comprising no or minimal contrast), and a second fluidincluding contrast (e.g. a second fluid comprising saline and contrast),such as to limit the amount of contrast delivered to the patient duringthe flush procedure. In these embodiments, injector 300 can comprise tworeservoirs (as described hereabove), such as a first reservoir forsupplying the first fluid and a second reservoir for supplying thesecond fluid. When comprised of two reservoirs, injector 300 can beconfigured to deliver the fluids in each reservoir at different rates,such as to achieve different pressures and/or to provide flushingthrough different catheters with different IDs.

As described herein, optical assembly 130 can be rotated (e.g. viarotation of core 120) and retracted (e.g. via retraction of shaft 110 byretraction assembly 220) during collection of image data, such as arotation combined with retraction to create a 3D image of the patientsite PS. In some embodiments, optical assembly 130 is rotated at a ratebetween 40 rps and 1000 rps, such as a rate of approximately 250 rps. Insome embodiments, optical assembly 130 is rotated at a first rate duringan imaging mode, and a second rate during a preview mode (imaging modeand preview mode each described hereabove). In some embodiments, theretraction of optical assembly 130 spans of distance of between 1 cm and15 cm, such as a retraction of approximately 4 cm. In some embodiments,optical assembly 130 is retracted at a rate of between 1 mm/sec and 60mm/sec. In some embodiments, the retraction of optical assembly 130comprises a retraction of approximately 7.5 cm over 4 seconds and/or aretraction rate of approximately 20 mm/sec. In some embodiments,retraction of optical assembly 130 comprises a resolution of between 5μm and 20 μm axially and/or a resolution between 20 μm and 100 μmlongitudinally. The longitudinal resolution is governed by two factors:the spot-size (light beam cross-section) at the tissue surface beingimaged and the spacing between successive rotations of optical assembly130 during retraction. For a rotation rate of 100 rps and a pullbackrate of 22 mm/sec, a pitch of 200 μm between rotations results. In theseconfigurations, a spot size between 20 μm and 40 μm would result incollecting image data which under-samples the objects being imaged.System 10 can be configured to more closely match spot size with pitch,such as by correlating spot size with rotation rate and/or pullbackrate.

In some embodiments, imaging system 10 is constructed, arranged and usedto create an image as described in applicant's co-pending U.S.Provisional Application Ser. No. 62/212,173, titled “Imaging Systemincludes Imaging Probe and Delivery Devices”, filed Aug. 31, 2015; thecontent of each of which is incorporated herein by reference in itsentirety for all purposes.

In some embodiments, system 10 is configured to assist in the selection,placement and/or use of a treatment device 91. Treatment device 91 cancomprise a stent retriever configured to remove thrombus or otherocclusive matter from a patient, such as when imaging probe 100 imagesthe anatomy and/or the treatment device 91 to produce anatomicalinformation (e.g. used to select the size or other geometry of the stentretriever), visualize the stent retriever at the occlusive site (e.g. toposition treatment device 91), and or visualize occlusive matter (e.g.thrombus) engaged with and/or not removed by the treatment device 91. Insome embodiments, system 10 is configured to quantify a thrombus volume,such as a thrombus to be removed by a treatment device 91. Thrombusvisualized by system 10 can comprise thrombus selected from the groupconsisting of: residual thrombus in acute stroke; thrombus remainingafter a thrombus removal procedure; thrombus present after flow diverterimplantation; and combinations thereof.

In some embodiments, system 10 is configured to provide anatomicalinformation to be used to select a site of implantation and/or to selecta particular implantable device to be implanted in the patient, such asimplant 85 of system 10 described hereabove. System 10 can be configuredto image at least one perforator artery of the patient, such as to imageone, two or more perforator arteries of at least 50 μm in diameter.Implant 85 can be implanted in the patient via implant delivery device80, such as when implant 85 comprises a stent and/or a flow diverter.System 10 can be configured to perform a function selected from thegroup consisting of: detect and/or quantify implant 85 apposition (e.g.a stent or flow diverter malapposition); provide quantitative and/orqualitative information regarding the size and/or placement of animplant 85 to be implanted in a patient, such as information related toperforator location; perforator geometry, neck size and/or flow divertermesh density; and combinations of one or more of these. System 10 can beconfigured to provide information related to an implant 85 parameterselected from the group consisting of: porosity; length; diameter; andcombinations thereof. System 10 can be configured to provide implant 85porosity information comprising the porosity of one or more portions ofimplant 85, such as a portion to be positioned proximate a sidebranch ofa vessel in which implant 85 is implanted. System 10 can be configuredto provide porosity information based on a wire diameter of implant 85.System 10 can be configured to provide information related to theimplantation (e.g. implantation site or device information) of a secondimplant 85 to be implanted in the patient. In these embodiments in whichtwo implanted devices 85 are used, the first and second implanteddevices can comprise similar or dissimilar devices (e.g. a stent and aflow diverter, two stents or two flow diverters). System 10 can beconfigured to collect image data during deployment of one or moreimplants 85. System 10 can be configured to collect image data used tomodify an implanted device (e.g. during and/or after implantation), suchas to modify the porosity of implant 85 (e.g. via a treatment device 91comprising a balloon catheter used to adjust the porosity of a partiallyor fully implanted implant 85).

Imaging conventionally inaccessible areas of the body (e.g. coronaryarteries, neurovascular arteries, the endocrine system, pulmonaryairways, etc.) using specialized catheters has been in use for severaldecades. Even so, products for these applications are still being widelydeveloped as technological advances allow higher resolution, newmodalities (e.g. spatially-resolved spectroscopy), and lower cost probesto be realized. Limitations and other issues with the current cathetersare described herebelow. Such imaging catheters commonly utilizehigh-speed rotation of distally-located optics to create a crosssectional view of a body lumen since reduced diameter imaging cathetersgenerally precludes the use of conventional optics or so-called coherentfiber bundles. Rather than creating a multi-pixel conventional‘snapshot’, the image with rotating optics is built up one or two pixelsat a time by scanning a single imaging spot, similar to the raster scanemployed by older CRT's. This rotation may be coupled with alongitudinal motion (‘pull-back’) to create a spiral scan of the arteryor lumen, which can be rendered as a 3-D image. The majority ofcurrently available imaging catheters have a distally located imagingelement, connected optically or electrically to a proximal end. Theimaging element is attached to a mechanical transmission that providesrotation and pullback to occur. Recently, advances in micro-motortechnology can supplant the mechanical transmission with distallylocated actuation, but pullback is still required. However, these motorsare expensive and relatively large (available designs do not allowprobes below 1 mm OD to be constructed).

There are a number of commercially available “torque shafts” which areminiature wire-wound tubes intended to transmit torque over a long andflexible shaft. Such devices are now commonly used in intravascularultrasound (IVUS) procedures as well as OCT procedures. Imaging probescombined with torque shafts perform rotational scanning in coronaryarteries for example. Generally however, these devices are approximately0.8 to 1.3 mm in OD, (2.4 Fr to 4 Fr) and are thus 2 to 4 times largerthan the devices required by neurological applications. Presently, suchtorque wires are not scalable to the sizes required to permit theconstruction of scanning imaging catheters less than 0.7 mm in OD.

Since optical imaging in arteries necessitates the clearing ofobfuscating blood, usually with a flush solution, the imaging catheterdiameter becomes critically important in smaller or obstructed vessels(e.g. due to use of smaller guides). Since it is often diseased orobstructed vessels that require imaging for diagnosis and treatment,imaging probe 100 can be designed for a small diameter (e.g. an OD lessthan or equal to 0.025″, 0.016″ or 0.014″).

As has been previously disclosed (Petersen, et al U.S. Pat. No.6,891,984 [the '984 patent]; Crowley U.S. Pat. No. 6,165,127 [the '127patent], the content of each of which is incorporated herein byreference in its entirety for all purposes), using a viscous fluidlocated at the distal region of the imaging catheter is provided toprevent twisting.

Achieving uniform rotational scanning at the distal tip of a singlefiber imaging catheter, while maintaining an overall device size lessthan 500 μm in OD is a significant challenge. Because it is currentlyimpractical to add a motor to the distal tip that is sized less than 1mm in OD (see Tsung-Han Tsai, Benjamin Potsaid, Yuankai K. Tao,Vijaysekhar Jayaraman, James Jiang, Peter J. S. Heim, Martin F. Kraus,Chao Zhou, Joachim Hornegger, Hiroshi Mashimo, Alex E. Cable, and JamesG. Fujimoto; “Ultrahigh speed endoscopic optical coherence tomographyusing micro-motor imaging catheter and VCSEL technology”, Biomed OptExpress. 2013 Jul. 1; 4(7): 1119-1132), with the attendant wires andsize issues, a way must be found to apply torque to the proximal end andtransmit the torque to the distal tip (which may be as much as threemeters away in some clinical applications) while maintaining uniformrotational speed. Uniform speed is paramount to image fidelity asnon-uniform rotation can lead to image smearing and severe distortions(See FIG. 3). If the extremely low inherent rotational stiffness of aglass fiber is considered, the issues of uniformly spinning the distaltip by driving the proximal end can be appreciated. Uniform rotation iscritically important in endoscopic techniques in order to obtainaccurate circumferential images. The term ‘NURD’ (non-uniform rotationaldistortion) has been coined in the industry to describe thesedeleterious effects.

An example of distortion caused by non-uniform rotational distortion(NURD) is shown in FIG. 3. The solid curve is a simulated perfectlyround artery, 4 mm in diameter. The curve with square data points is theimage of the same arterial wall with NURD. In this case, the catheterrotation is slowed by 50% over a small portion of the cycle, and sped upby 50% in another portion, such that the average distal rotational speedmatches the proximal rotational speed (as it must, otherwise rapidlyaccumulating twist would cause the core 120 to break). It can be seenthat this NURD can lead to significant measurement errors. The imagingprobe 100 and other components of system 10 are configured to reducethese types of distortions.

The '127 patent discloses the use of a viscous fluid located inside thebore of an ultrasound catheter. The purpose of the fluid is to provideloading of a torque wire such that the wire enters the regime of hightorsional stiffness at moderate spin rates. As described in the '127patent, this fluid is housed within a separate bore formed inside themain catheter, increasing the overall size of the device. The fluid doesnot contact the imaging tip, nor does the ultrasound energy propagatethrough this fluid. This approach also requires the use of a torquewire, limiting the achievable reduction in size needed. In the imagingprobe of the present inventive concepts, one or more viscous fluids(e.g. one or more fluids 190) can be provided to deliberately causetwisting (i.e. winding) of core 120. The twisting can comprise dynamictwisting that changes with total (i.e. end-to-end) frictional load(torque) of probe 100, to result in a relatively constant rotationalrate. Probe 100 can be configured such that the amount of twistingchanges during a pullback of one or more portions of probe 100 (e.g. apullback of core 120 and/or a pullback of core 120 and shaft 110).

The '984 patent utilizes a viscous fluid with a high index of refractionto simultaneously reduce refractive effects at the curved sheathboundary as well as provide viscous loading to allow an optical fiber tobe the torque transmitter. This configuration allows a certain reductionin size. However, the '984 patent fails to describe or disclose amechanism for confining the fluid at the distal tip within the geometryconstraints; unavoidable migration of this fluid during transport andstorage will cause unavoidable loss of performance. Similarly, the '984patent fails to address issues that could arise during pullback of theinternal fiber which will cause voids to form in the viscous fluid,these voids causing relatively large optical effects (so-called‘bubble-artifacts’, see, for example, “Expert review document onmethodology, terminology, and clinical applications of optical coherencetomography: physical principles, methodology of image acquisition, andclinical application for assessment of coronary arteries andatherosclerosis”, Francisco Prati, et al, European heart Journal, Nov.4, 2009). In some embodiments, probe 100 is configured to rotate core120 in a single direction (i.e. unidirectional) during use. In someembodiments, probe 100 comprises a torque shaft within shaft 110 andfrictionally engaged with core 120, such as torque shaft 110 b describedherebelow. Torque shaft 110 b can extend from the proximal end of probe100 to a location proximal to optical assembly 130, such as a torqueshaft with a distal end that is located at least 5 cm from opticalassembly 130, or a distal end that is located proximal to the mostproximal location of shaft 110 that is positioned within the patient.

A liquid, gel or other fluid-filled (e.g. and sealed) imaging probe 100has the advantage that it does not require purging (e.g. to remove airbubbles). The fluid 190 a or 190 b can be configured as a lubricant,reducing friction between core 120 and shaft 110. In embodiments inwhich core 120 is pulled back relative to shaft 110 to obtain an image,a void is created at the end of core 120 that can be filled with liquid,gel or other fluid (e.g. fluid 190).

It is difficult for fluid to “fill in” this region as it must beprovided from the proximal end of shaft 110 and travel the length of thecore 120. Bubbles are likely to form here as a low pressure can begenerated. In embodiments of the present inventive concepts, rather thanretracting the core 120 within shaft 110, the entire imaging probe 100is pulled back during image data collection (i.e. core 120 and shaft 110are retracted in unison without relative axial motion between the two).Since the shaft 110 moves along with the core 120, the presence of alow-pressure region at the end of the imaging core is eliminated or atleast mitigated.

As shown in FIG. 4, such “mutual” motion of shaft 110 and core 120allows shaft 110 to have a larger diameter around optical assembly 130,as relative motion between optical assembly 130 and shaft 110 isavoided. A larger diameter optical assembly 130 (e.g. a larger diameterlens of optical assembly 130) provides collection of more light, whichcan correlate to a brighter image. This configuration can also provide alens of optical assembly 130 that has a focal length that is positionedfarther away from the OD (i.e. outer surface) of shaft 110 surroundingoptical assembly 130, improving distal image quality. Alternatively oradditionally, and also as shown in FIG. 4, optical assembly 130 cancomprise an OD that is larger than an ID of at least a portion of shaft110 proximal to optical assembly 130. In these embodiments, opticalassembly 130 and shaft 110 can be retracted simultaneously duringcollection of image data from a target area.

In some embodiments, the shaft 110 wall is relatively thicker over amajority of its length as compared to a thinner wall of shaft 110 at adistal portion of shaft 110 (e.g. thinner at a shaft 110 portionproximate optical assembly 130). Such a configuration allows forimproved longitudinal and torsional control for positioning of imagingprobe 100. In some embodiments, shaft 110 can comprise a stiffenedportion positioned about optical assembly 130, such as a stiffenedsegment of shaft 110 comprising: a different (stiffer) wall material; abraided shaft portion; and or a stiffening element (e.g. a wire embeddedin the wall of shaft 110). The stiffened distal portion of shaft 110 cancorrelate to a thinner wall, which in turn correlates to opticalassembly 130 comprising larger optical components (e.g. one or morelarger diameter lenses), for example without having to increase the ODof shaft 110 surrounding optical assembly 130. In some embodiments,shaft 110 has varying mechanical properties along its length (e.g. astiffened proximal segment for “push-ability”), and a graduallydecreasing stiffness distally (e.g. to improve deliverability and safetyas advanced into tortuous anatomy).

Also as shown in FIG. 4, optical assembly 130 can comprise a lens 131and a reflecting element 132 (e.g. to “turn” the light). Reflectingelement 132 is configured such that optical assembly 130 isasymmetrical. When optical assembly 130 is spun at high speed, thepresence of viscous liquids or other viscous fluids in the optical pathsurrounding optical assembly 130 could, in some cases, cause cavitationin the region behind reflector 132. As shown in FIG. 5, in someembodiments, probe 100 includes a first fluid, fluid 190 a thatsurrounds core 120, and a second, different fluid, fluid 190 b, thatsurround optical assembly 130, such that fluid 190 a can be configuredto provide a first function (e.g. prevent or at least reduce undesiredrotational variances of core 120), while fluid 190 b provides a secondfunction (e.g. prevent or at least reduce cavitation about opticalassembly 130). In some embodiments, the viscosity of fluid 190 b can beselected to be relatively low viscosity, such as to minimize cavitation,while the viscosity of fluid 190 a can be selected to be relatively high(e.g. at least more viscous than fluid 190 b) to optimize uniformity inthe rotational speed.

In neurological placement, imaging probe 100 is usually placed into afemoral vessel of the patient. There is significant tortuosity in thevasculature proximal to a neurological imaging area, starting with thecarotid artery take off from the aorta. In some embodiments, the use ofa high viscosity fluid 190 a in the mid and/or proximal section ofimaging probe 100 allows the fluid 190 a to provide the additionalfunction of lubricating the spinning core 120 in the shaft 110 (e.g.lubrication of benefit due to the high tortuosity in which imaging probe100 is placed). The reduced friction that results reduces the stress onthe core 120, and allows smoother motions over any discontinuities inshaft 110 or core 120. Fluid 190 can be configured to provide sufficientlubrication or other advantageous parameter to eliminate or at leastreduce (“reduce” herein) adverse effects that would otherwise occur asprobe 100 is positioned in tortuous anatomy (e.g. when distal portion119 a is positioned proximate and distal to the carotid artery). Inthese embodiments, fluid 190 can comprise a high viscosity fluid.

Additionally, the presence of a high viscosity fluid 190 a helpsmaintain the lower viscosity fluid 190 b in the distal end of shaft 110prior to use, as the higher viscosity fluid 190 a in shaft 110 operatesas a barrier, and reduces the likelihood of fluid 190 b migration fromthe imaging region about optical assembly 130 prior to use (e.g. duringsterilization and shipping of imaging probe 100). In some embodiments, asealing element, such as sealing element 116, is positioned between twoor more different fluids 190. Alternatively, no separating element maybe present, such as when one or more of the fluids 190 comprise a gelconfigured not to mix with a neighboring fluid 190.

In some embodiments, imaging probe 100 includes an inertial assemblycomprising an impeller, propeller or other inertia-based elementconfigured to reduce undesired variances in rotational speed of opticalassembly 130, such as is shown in FIG. 6. Imaging probe 100 comprisesimpeller 182 that is attached to the core 120. Drag on impeller 182“winds up” core 120 and decreases unintended or otherwise undesiredvariances in rotational velocity of the fiber. Impeller 182 operates tospin the fluid 190 between shaft 110 and optical assembly 130. Theimpeller 182 blades form drag, which due to its symmetry around itsrotational axis, remains uniform through the rotation. In someembodiments, the radial extending ends of impeller 182 intentionallycontact an inner wall of shaft 110, to alternatively or increasinglyprovide drag. Impeller 182 can comprise one or more projections fromcore 120, such as projections that frictionally engage shaft 110 and/orotherwise cause shear force that applies a load to core 120 duringrotation. Impeller 182 can comprise one or more projections from shaft110, such as projections that frictionally engage core 120 and/orotherwise cause shear force that applies a load to core 120 duringrotation.

Impeller 182 can be configured to cause wind-up loading of core 120.Impeller 182 can be configured to frictionally engage fluid 190 and/orshaft 110 during rotation of core 120. Impeller 182 can comprise acomponent selected from the group consisting of: turbine; vane-typemicro-structure; flywheel; and combinations of one or more of these.

Liquid, gel or other fluid positioned inside shaft 110 can have atendency to form bubbles. If these bubbles are in the optical path theywill reduce the light transmission. In some embodiments, fluid 190 aand/or fluid 190 b (singly or collectively fluid 190) can be pressurized(e.g. to a pressure of 100 psi or above) to prevent or at least reducethe size of any bubbles in shaft 110, such as is described herein inreference to FIG. 7.

Small tire inflators are commonly used for filling bicycle tires. Theyare available in sizes smaller than 1 inch, which is suitable for thisapplication. These and similarly configured inflators can providepressures up to and beyond 100 psi, which when applied to fluid 190 cansignificantly reduce the bubble size. Assuming a bubble size atatmospheric pressure is to be 0.1 microliters, the bubble size at 100psi can be calculated as:

V _(p) =V _(a) P _(a) /P _(p)

where:

V_(p)=Bubble volume under pressure

V_(a)=Bubble volume at atmospheric pressure (e.g. 0.1 μL)

P_(a)=Atmospheric pressure (14.7 PSI)

P_(p)=Pressurizing device pressure (e.g. 100 psi)

Under pressurization, the bubble volume decreases from 0.1 μL to 0.0147μL. The corresponding bubble diameter is reduced from 0.022″ to 0.011″,which will mitigate or eliminate deleterious effects on the opticalbeam.

FIG. 7 is a sectional view of an imaging probe including apressurization system, consistent with the present inventive concepts.Imaging probe 100 comprises shaft 110 with proximal end 111, lumen 112,core 120 and optical connector 102, each of which can be of similarconstruction and arrangement as those described hereabove in referenceto FIG. 1. Imaging probe 100 can include pressurization assembly 183(e.g. a pressurized gas canister) which can be fluidly connected tolumen 112 via valve 184 (e.g. a one way check valve). In someembodiments, each imaging probe 100 is provided with a pressurizationassembly 183. Alternatively, a single pressurization assembly 183 can bereused (e.g. used on multiple imaging probes 100 in multiple clinicalprocedures). In some embodiments, pressurization assembly 183 can bepre-attached to shaft 110, or separated and attachable. In someembodiments, pressurization assembly 183 can be operably attached and/oractivated just prior to the time of clinical use of imaging probe 100,such as to pressurize fluid within lumen 112 or other imaging probe 100internal location, such as to reduce the size of one or more gas bubblesin a fluid, such as fluid 190 described herein.

In some embodiments, at a location near to proximal end 111 of shaft110, sealing element 151 (e.g. a compressible O-ring) is positionedbetween core 120 and shaft 110. Shaft 110 and sealing element 151 can beconstructed and arranged to maintain a relative seal as lumen 112 ispressurized (e.g. as described above), while allowing core 120 to rotatewithin shaft 110 and sealing element 151. Sealing element 151 canprovide a seal during rotation of core 120 within shaft 110. Retractionof shaft 110 and core 120 simultaneously during imaging, as describedherein, simplifies the design of sealing element 151. In somealternative embodiments, core 120 is retracted within shaft 110, andsealing element 151 is configured to maintain a seal during thatretraction.

In some embodiments, at least a portion of shaft 110 is configured toradially expand as fluid 190 is pressurized, such as is shown in FIGS.15A-C. Pressurization assembly 183 is attached to connector 102 suchthat fluid 190 can be introduced and/or pressurized into and/or withinshaft 110. In FIG. 15A, proximal portion 111 a of shaft 110 is expanded(e.g. lumen 112 is expanded in the region of proximal portion 111 a). InFIG. 15B, proximal portion 111 a and mid portion 115 of shaft 110 areexpanded. In FIG. 15C, proximal portion 111 a, mid portion 115 anddistal portion 119 a are expanded. In these embodiments, system 10 canbe configured to rotate core 120 after shaft 110 has been fully expandedas shown in FIG. 15C. Expansion of shaft 110 can create and/or increasespace between core 120 and the inner wall of shaft 110. In someembodiments, shaft 110 remains at least partially expanded (e.g. shaft110 has been plastically deformed) when the pressure of fluid 190 isdecreased (e.g. to atmospheric pressure). Shaft 110 can be configured toexpand to a first diameter (ID and/or OD) when fluid 190 is pressurizedto a first pressure, and to expand to a second, larger diameter, whenfluid 190 is pressurized to a second, higher pressure. In someembodiments, shaft 110 is configured to become more rigid as thepressure of fluid 190 increases.

There can be two attachments from probe 100 (e.g. a disposable catheter)to the non-disposable components of system 10. One is attached to shaft110 (a non-rotating shaft) and the other to core 120. Attachment ofimaging probe 100 to console 200 can comprise two functionalattachments. One attachment comprises attachment of shaft 110 to aretraction assembly, such as retraction assembly 220 described herein,such that shaft 110 (and optic assembly 130) can be retracted duringcollection of image data. Another attachment comprises attaching core120 to a rotational assembly, such as rotation assembly 210, such thatcore 120 can be rotated during collection of image data. Bothattachments can be retracted together during collection of image data.The attachment of core 120 makes the optical connection between core 120and an imaging assembly (e.g. imaging assembly 230 described herein) andcan provide the motive power to rotate core 120 (e.g. an attachment torotation assembly 210).

The imaging system and associated imaging probes of the presentinventive concepts provide enhanced compatibility with traditionaltherapeutic catheters, such as those used in neurological procedures asdescribed herein.

Stent retrieval devices (also referred to as “stent retrievers”) areused for endovascular recanalization. While the rate of successfulrevascularization is high, multiple passes of the stent retrieval deviceare often required to fully remove the clot, adding to procedure timesand increasing likelihood of complications. The addition of imaging to astent retrieval procedure has the potential to reduce both proceduretime and complications. In FIGS. 8-11, system 10 comprises imaging probe100 and a therapeutic device, treatment device 91. While treatmentdevice 91 is shown as a stent retriever, other therapeutic devices wouldbe applicable, such as a treatment device 91 selected from the groupconsisting of: stent retriever; embolization coil; embolization coildelivery catheter; stent; covered stent; stent delivery device; aneurysmtreatment implant; aneurysm treatment implant delivery device; flowdiverter; balloon catheter; and combinations thereof. Imaging probe 100and treatment device 91 have been placed into a vessel, such as a bloodvessel of the neck or head. Imaging probe 100 and treatment device 91can be insertable into a single catheter, such as delivery catheter 50 dshown.

Positioning of optical assembly 130 and resulting images produced assurecorrect placement of the treatment device 91 (e.g. positioning of thestent retriever distal to the thrombus) and also assures that therapy iscompleted successfully (e.g. sufficient thrombus has been removed),which can both reduce procedure times and improve clinical results.

In some embodiments, system 10 comprises delivery catheter 50 a (notshown, but such as a 6-8 Fr guide catheter) that can be placed into atarget vessel (e.g. artery), such as by using transfemoral access. Insome embodiments, delivery catheter 50 a comprises a standard balloonguide catheter, such as to prevent distal thrombus migration and toenhance aspiration during thrombectomy. System 10 can further comprisedelivery catheter 50 b (not shown but such as a flexible 5-6 Frcatheter) that is used as an intermediate catheter, advanced throughdelivery catheter 50 a to gain distal access close to the occludedsegment of the vessel. System 10 can comprise a third delivery catheter50 c, shown, such as a 0.021″ to 0.027″ microcatheter used to cross thethrombus or otherwise provide access to a target site to be treatedand/or imaged. Angiographic runs can be performed through the deliverycatheter 50 c to angiographically assess the proper position of thedelivery catheter 50 c tip (e.g. position of tip distal to the thrombusand to estimate the length of the clot). The treatment device 91 (e.g.the stent retriever shown) is subsequently released by pulling backdelivery catheter 50 c while holding the treatment device 91 in place.In some embodiments, the treatment device 91 should cover the entirelength of an occlusion in order to achieve flow restoration (e.g. whenthe stent portion opens).

In FIG. 8, a distal portion of delivery catheter 50 c has beenpositioned in a blood vessel (e.g. within a vessel location includingthrombus). A stent portion of treatment device 91 remains undeployed,captured within the distal portion of delivery catheter 50 c. In FIG. 9,delivery catheter 50 c is retracted, such that the stent portion oftreatment device 91 deploys (e.g. to engage thrombus, thrombus notshown). In FIG. 10, imaging probe 100 is advanced through the deployedstent portion of treatment device 91. Image data can be collected duringthe advancement. In FIG. 11, imaging probe 100 is being retracted(optical assembly 130 passes through the stent portion of treatmentdevice 91) as image data is collected, such as to perform a proceduralassessment as described herein.

In some embodiments, system 10 is constructed and arranged such thatproximally applied torque (e.g. to core 120) and distally appliedrotational speed control (e.g. to core 120 and/or optical assembly 130)is provided. This configuration has several benefits, including but notlimited to: small size; low-cost; and an independence from the tortuouspath proximal to the distal tip of imaging probe 100.

In some embodiments, system 10 is configured to provide preciserotational control (e.g. avoid undesired rotational speed variances ofcore 120 and/or optical assembly 130) via inertial damping, such asinertial damping which increases with rotational speed. This control canbe accomplished with: a viscous fluid in contact with core 120 and/oroptical assembly 130 (e.g. fluid 190 a and/or 190 b described herein); afluid in contact with a mechanical load such a vane-typemicro-structure; a mechanical load acting as a flywheel; andcombinations thereof.

In some embodiments, imaging probe 100 comprises a guidewire independentdesign, comprising a shaft 110 with an OD of 0.016″ or less (e.g.approximately 0.014″), and configured such that its shaft 110, core 120and optical assembly 130 are retracted in unison using external pullback(e.g. retraction assembly 220 described herein).

In some embodiments, imaging probe 100 is configured to be advancedthrough vessels to a target site with or without the use of amicrocatheter.

In some embodiments, imaging probe 100 is configured such that core 120and optical assembly 130 are configured to be retracted within shaft 110during image data collection, such as an internal pullback using purgemedia (e.g. fluid 190 or other purge media introduced between the core120 and the shaft 110). In some embodiments, the introduced material isconfigured to provide a function selected from the group consisting of:index matching; lubrication; purging of bubbles; and combinationsthereof.

In some embodiments, imaging probe 100 comprises an Rx tip. In theseembodiments, imaging probe 100 can be configured such that core 120 andoptical assembly 130 are configured to be retracted within shaft 110during image data collection.

In some embodiments, imaging probe 100 comprises a highly deliverable,very small cross-section probe. In some embodiments, shaft 110 comprisesone or more optically transparent materials providing an opticallytransparent window, viewing portion 117, positioned within distalportion 119 a of shaft 110. Viewing portion 117 can comprise a lengthbetween 1 mm and 100 mm, such as a length of approximately 3 mm. In someembodiments, viewing portion 117 can comprise a length less than 50 mm,such as less than 20 mm or less than 15 mm (e.g. a relatively shortwindow in embodiments in which both shaft 110 and optical assembly 130are retracted simultaneously during the collection of image data).Viewing portion 117 can comprise a material selected from the groupconsisting of: nylon; nylon 12; nylon 66; and combinations of one ormore of these. In some embodiments, at least a portion of shaft 110comprises a reinforced portion, such as a reinforced portion comprisinga stiffening element (e.g. stiffening element 118 shown in FIG. 1). Insome embodiments, stiffening element 118 terminates proximal to opticalassembly 130 (e.g. proximal to viewing portion 117 of shaft 110).Alternatively, stiffening element 118 can extend beyond optical assembly130, such as is shown in FIG. 2, and the pullback geometry can becoordinated such that the light path to and from optical assembly 130avoids the stiffening element 118. Stiffening element 118 can beincluded to resist twisting of distal portion 119 a, such as duringrotation of the core 120. For example, stiffening element 118 cancomprise an element selected from the group consisting of: a coil; ametal coil; a metal coil wound over a plastic such as PTFE; a tube; ametal tube; a metal and/or plastic braid positioned within the wall ofshaft 110; and combinations thereof. In some embodiments, shaft 110comprises a stiffening element 118 comprising a coil wound in adirection such that rotation of the core 120 tends to cause the coil totighten (e.g. to further resist twisting of shaft 110). In someembodiments, one or more portions of stiffening element 118 come intocontact with a fluid maintained within shaft 110 (e.g. fluid 190described herein), such that twisting of shaft 110 is reduced by torqueforces applied by the fluid to stiffening element 118.

In some embodiments, system 10 includes integration of imaging probe 100with one or more therapeutic devices (e.g. one or more treatment devices91). For example, a treatment device 91 can comprise a stent retriever,and system 10 can provide real time simultaneous visualization of one ormore of: the patient's anatomy (e.g. blood vessel wall and other tissueof the patient); the treatment device 91 (e.g. one or more struts oftreatment device 91); and/or thrombus or other occlusive matter. Thesimultaneous visualization can be correlated to reduced procedure timeand improved efficacy.

In some embodiments, system 10 is configured to apply proximal pressureto imaging probe 100, such as to keep the distal portion bubble-free orat least to mitigate bubble generation within one or more fluids 190 ofimaging probe 100.

As described herein, imaging probe 100 can comprise a core 120 includinga thin fiber that can be optically coupled on its distal end to opticalassembly 130 comprising a lens assembly. In some embodiments, a fluidinteracting element (e.g. a coil or length of wound wire, though notnecessarily a torque wire), can be positioned just proximal to opticalassembly 130 (e.g. embedded in the wall of or within shaft 110). In someembodiments, the shaft 110 can be filled with a low viscosity fluid 190,such as to interact with the fluid interacting element and create drag.The coil or other fluid interacting element, in contrast to aconventional torque wire, is not wound to create a high-fidelitytransmission of torque but to increase viscous drag. The fluid 190 canbe low viscosity (e.g. with a viscosity at or below 1000 Cp) to allowfor easier filling and will reduce bubble artifacts created in highviscosity solutions. The fluid interacting element can comprise animpeller, such as impeller 182 described herein. The fluid interactingelement comprises a non-circular cross section portion of a portion ofshaft 110, such as a cross section with a geometry selected from thegroup consisting of: polygon shaped cross section of a lumen of shaft110; projections into a lumen of shaft 110; recesses in inner diameter(i.e. the inner wall) of shaft 110; and combinations of one or more ofthese.

In some embodiments, imaging probe 100 comprises a formed element tocreate viscous drag, such as impeller 182 described herein. This elementcan have a variety of shapes designed to maximize the interaction withan internal fluid 190.

In some embodiments, imaging probe 100 is constructed and arranged suchthat viscous drag is created by mechanical friction between a partrigidly coupled to core 120 and in close contact with the wall of shaft110. The friction may be created by the shear force of a narrow annulusbetween the mechanical element and the shaft 110 wall, such as when theshaft 110 is filled with fluid 190.

In some embodiments, imaging probe 100 comprises at least one fluid 190that is contained by at least one sealing element (e.g. sealing element116 and/or sealing element 151 described herein). Sealing element 116and/or 151 can be constructed and arranged to allow core 120 to rotatein the sealed region while preventing the (viscous) fluid 190 topenetrate through the seal. In some embodiments, two sealing elements116 a and 116 b are included, such as one positioned just proximal tothe optical assembly 130 and one positioned further distal, such as isshown in FIG. 17. In these embodiments, the separation distance betweenthe two sealing elements 116 and/or the viscosity of the captured fluid190 can be chosen to create sufficient torsional loading as core 120 isrotated. In some embodiments, the two sealing elements 116 a and 116 bare positioned apart at a distance between 1 mm and 20 mm. In someembodiments, the fluid 190 comprises a viscosity between 10 Cp and 100Cp.

In some embodiments, system 10 comprises an imaging probe 100 and aconsole 200. Imaging probe 100 comprises: a proximal end 111 and adistal end 119, and at least one lumen 112 extending between theproximal end 111 and the distal end 119. Core 120 is positioned withinlumen 112, the proximal end of core 120 in optical and mechanicalcommunication with console 200, and the distal end of core 120 inoptical communication with an optical assembly configured to collectimage data within a body lumen.

In some embodiments, imaging probe 100 comprises optical assembly 130located at the distal end of core 120, optical assembly 130 inmechanical and optical communication with core 120, the optical assembly130 directing light to the target (e.g. thrombus, vessel wall, tissueand/or implant) being imaged and collecting return light from the imagedtarget. Imaging probe 100 can further comprise an inertial system (e.g.impeller 182) located proximate the distal end of the core 120, whereinthe inertial system reduces undesired rotational speed variances thatoccur during a rotation of the core 120. The inertial system cancomprise a (predetermined) length of wound hollow core cable, the distalend of the cable being affixed to core 120 just proximal to opticalassembly 130, the proximal end unattached (e.g. not attached to core120). The inertial system can comprise a mechanical resistance elementlocated in the distal region of core 120, and can be in contact with afluid 190 confined within a lumen 112 of shaft 110, the mechanicalresistance arising during rotation within the fluid 190.

In some embodiments, imaging probe 100 comprises a sealing element, suchas sealing element 151 described herein, located within lumen 112 ofshaft 110. Sealing element 151 can be configured to allow rotation ofcore 120 while forming substantially liquid-tight seals around core 120and the inner wall of shaft 110. In some embodiments, sealing element151 is further configured as a mechanical resistance element. In someembodiments, sealing element 151 is formed from a hydrogel. In someembodiments, the sealing element 151 is formed by an adhesive (e.g. aUV-cured adhesive), bonding to the inner wall of shaft 110, but not thesurface of core 120. In some embodiments, the surface of core 120 isconfigured to avoid bonding to an adhesive (e.g. a UV adhesive). In someembodiments, the sealing element 151 is formed from a compliant materialsuch as a silicone rubber.

In some embodiments, an imaging system comprises an imaging probe 100and an imaging console, console 200. The imaging probe 100 comprises: aproximal end 111, a distal end 119, and at least one lumen 112 extendingbetween the proximal end 111 and distal end 119. The imaging probefurther comprises: a core 120 contained within a lumen 112 of the shaft110, the proximal end of core 120 in optical and mechanicalcommunication with console 200, the distal end optically connected to anoptical assembly 130 configured to collect image data within a bodylumen. Optical assembly 130 is positioned at the distal end of the core120, and is configured to direct light to the target (e.g. thrombus,vessel well, tissue and/or implant) being imaged and collecting returnlight from the imaged target.

In some embodiments, imaging probe 100 comprises a core 120 and one, twoor more inertial elements, such as impeller 182 described herein,attached to optical assembly 130 and/or core 120 (e.g. attached to adistal portion of core 120). Impeller 182 can be configured such thatwhen the core 120 is retracted (e.g. in the presence of liquid, gel orgaseous medium, such as fluid 190), the impeller 182 imparts arotational force to core 120, such as to reduce undesired rotationalspeed variances. Impeller 182 can comprise a turbine-like construction.

In some embodiments, system 10 comprises an imaging probe 100 and animaging console, console 200. Imaging probe 100 comprises a proximal end111, a distal end 119, and at least one lumen 112 extending betweenproximal end 111 and distal end 119. Imaging probe 100 can furthercomprise a rotatable optical core, core 120 contained within a lumen 112of shaft 110, the proximal end of core 120 in optical and mechanicalcommunication with console 200, and the distal end configured to collectimage data from a body lumen.

As described herein, imaging probe 100 comprises optical assembly 130which is positioned at the distal end of core 120. Optical assembly 130is in mechanical and optical communication with core 120, and isconfigured to direct light to tissue target being imaged and collectreturn light from the imaged target. Imaging probe 100 can furthercomprise a reinforcing or other stiffening element (e.g. stiffeningelement 118 described herein) embedded into shaft 110 that creates animproved stiffness but effectively optically transparent window forrotational and pullback scanning. Stiffening element 118 can comprise anembedded wire and/or a stiffening member (e.g. a plastic stiffeningmember) in shaft 110. Stiffening element 118 can comprise a spiralgeometry. As described hereabove, the spiral geometry of stiffeningelement 118 and a pullback spiral rotational pattern of optical assembly130 can be matched but offset by approximately one-half of the spiral ofstiffening element 118, such that an imaging beam of optical assembly130 passes between the stiffening 118 spirals during pullback of opticalassembly 130.

Referring now to FIG. 12, a side sectional view of the distal portion ofprobe 100 is illustrated, having been inserted into a vessel, such thatoptical assembly 130 is positioned within treatment device 91 (e.g. astent deployment device, stent retriever or other treatment device),consistent with the present inventive concepts. Probe 100 comprisesshaft 110, core 120, optical assembly 130, lens 131 and reflector 132,and those and other components of probe 100 can be of similarconstruction and arrangement to those described hereabove. In someembodiments, distal end 119 comprises a geometry and/or a stiffness toenhance advancement of distal end 119 through blood vessels and/or oneor more devices positioned within a blood vessel. For example, distalend 119 can comprise the bullet-shaped profile shown in FIG. 12.Alternatively or additionally, treatment device 91 can comprise aproximal portion (e.g. proximal end 91 a shown), which can be configuredto enhance delivery of distal end 119 through proximal end 91 a. In someembodiments, probe 100 comprises a spring tip, such as spring tip 104described hereabove.

Probe 100 and other components of system 10 can be configured to allow aclinician or other operator to “view” (e.g. in real time) the collectionof thrombus or other occlusive matter into treatment device 91, such asto determine when to remove treatment device 91 and/or how to manipulatetreatment device 91 (e.g. a manipulation to remove treatment device 91and/or reposition treatment device 91 to enhance the treatment). Theability to view the treatment can avoid unnecessary wait time and otherdelays, as well as improve efficacy of the procedure (e.g. enhanceremoval of thrombus).

Referring now to FIG. 13, a side sectional view of the distal portion ofprobe 100 is illustrated, consistent with the present inventiveconcepts. Probe 100 comprises shaft 110, lumen 112, core 120, opticalassembly 130, lens 131 and reflector 132, and those and other componentsof probe 100 can be of similar construction and arrangement to thosedescribed hereabove. In some embodiments, distal portion 119 a of shaft110 comprises a reinforcing element, stiffening element 118 a as shownin FIG. 13. Inclusion of stiffening element 118 a can allow the wall ofshaft 110 surrounding optical assembly 130 to be thin (e.g. thinner thanthe wall in a more proximal portion of shaft 110). Stiffening element118 a can comprise an optically transparent material as describedherein. Stiffening element 118 a can be configured to provide columnand/or torsional strength to shaft 110. In some embodiments, probe 100comprises a lumen narrowing structure, such as tube 114 shown positionedwithin lumen 112 of shaft 110. Tube 114 can be adhesively or at leastfrictionally engaged with the inner wall of shaft 110 or the outersurface of core 120. In some embodiments, tube 114 is simply aprojection from the inner wall of shaft 110 (e.g. part of shaft 110).Tube 114 can be configured to provide a function selected from the groupconsisting of: increase torsional strength of shaft 110; increase columnstrength of shaft 110; provide a capillary action between fluidsurrounding core 120 and/or optical assembly 130; and combinationsthereof. In some embodiments, probe 100 comprises fluid 190 a and/orfluid 190 b shown, such as is described hereabove. Fluid 190 a and fluid190 b can comprise similar or dissimilar fluids. In some embodiments,fluid 190 a and/or fluid 190 b comprise a low viscosity fluid asdescribed hereabove. In some embodiments, fluid 190 a and/or fluid 190 bcomprise a shear-thinning fluid as described hereabove.

Referring now to FIG. 14, a schematic of an imaging probe isillustrated, shown in a partially assembled state and consistent withthe present inventive concepts. Probe 100 can comprise a first portion,comprising a connector 102 a, outer shaft 110 a and spring tip 104,constructed and arranged as shown in FIG. 14. Probe 100 can furthercomprise a second portion, connector 102 b, torque shaft 110 b, core 120and optical assembly 130. Outer shaft 110 a, spring tip 104, core 120and optical assembly 130 and other components of probe 100 can be ofsimilar construction and arrangement to those described hereabove.Connector 102 b can be of similar construction and arrangement toconnector 102 described hereabove, such as to optically connect probe100 to console 200. Connector 102 a can be configured to surround andmechanically engage connector 102 b, such that connectors 102 a and/or102 b mechanically connect to console 200.

Torque shaft 110 b frictionally engages core 120 (e.g. via an adhesive),at least at a distal portion of torque shaft 110 b. Torque shaft 110 bcan be attached to connector 102 b via an adhesive or other mechanicalengagement (e.g. via a metal tube, not shown, but such as a tube that ispressed into connector 102 b). In some embodiments, a strain relief isprovided at the end of torque shaft 110 b, tube 121 shown. Tube 121 canbe configured to reduce kinking and/or to increase the fixation betweentorque shaft 110 b and core 120. Tube 121 and torque shaft 110 b canhave similar IDs and/or ODs.

During assembly, torque shaft 110 b, optical assembly 130 and core 120are positioned within shaft 110 a. Connector 102 a can be engaged withconnector 102 b to maintain relative positions of the two components.

Torque shaft 110 b can comprise one or more plastic or metal materials,such as when torque shaft 110 b comprises a braided torque shaft (e.g. abraid comprising at least stainless steel). Torque shaft 110 b cancomprise a length such that the distal end of torque shaft 110 bterminates a minimum distance away from optical assembly 130, such as alength of approximately 49 cm. In some embodiments, torque shaft 110 bcomprises a length such that none or a small portion of torque shaft 110b enters the patient. In these embodiments, retraction assembly 220 canbe positioned and engage shaft 110 at a location distal to the distalend of retraction assembly 220.

Referring now to FIGS. 15A-C, a series of side sectional views of animaging probe in a series of expansion steps of its shaft via aninternal fluid, consistent with the present inventive concepts. Probe100 comprises connector 102, shaft 110, core 120 and optical assembly130, and those and other components of probe 100 can be of similarconstruction and arrangement to those described hereabove. Shaft 110comprises proximal portion 111 a, mid portion 115 and distal portion 119a. Probe 100 further comprises pressurization assembly 183, which mayinclude valve 184, each of which can be of similar construction andarrangement to the similar components described hereabove in referenceto FIG. 7. Probe 100 can be configured such that as fluid is introducedinto lumen 112, and/or the pressure of fluid within lumen 112 isincreased, shaft 110 expands. For example, a first introduction of fluid190 into lumen 112 and/or a first increase of pressure of fluid 190 inlumen 112 (e.g. via pressurization assembly 183) can be performed suchthat the proximal portion 111 a of shaft 110 expands as shown in FIG.15A. Subsequently, a second introduction of fluid 190 into lumen 112and/or a second increase of pressure of fluid 190 in lumen 112 can beperformed such that the mid portion 115 of shaft 110 expands as shown inFIG. 15B. Subsequently, a third introduction of fluid 190 into lumen 112and/or a third increase of pressure of fluid 190 in lumen 112 can beperformed such that the distal portion 119 a of shaft 110 expands asshown in FIG. 15C. In some embodiments, shaft 110 is expanded to createa space between the inner wall of shaft 110 and core 120 and/or tocreate a space between the inner wall of shaft 110 and optical assembly130.

Referring now to FIG. 16, a side sectional view of the distal portion ofan imaging probe comprising a distal marker positioned in reference toan optical assembly is illustrated, consistent with the presentinventive concepts. Probe 100 comprises shaft 110, core 120, opticalassembly 130, lens 131 and reflector 132, and those and other componentsof probe 100 can be of similar construction and arrangement to thosedescribed hereabove. Shaft 110 comprises proximal portion 111 a (notshown), distal portion 119 a and distal end 119. Probe 100 can comprisea functional element 133 a, which can be positioned on or relative tooptical assembly 130 (e.g. positioned on or at a desired and/or knowndistance from optical assembly 130). Functional element 133 a is shownpositioned distal to optical assembly 130, and at a fixed distance asdetermined by a connecting element, tube 134 (e.g. heat shrink tubing orother plastic tube). In some embodiments, functional element 133 acomprises a sensor, transducer or other functional element as describedherein. In some embodiments, functional element 133 a comprises avisualizable element, such as a radiopaque element, ultrasonicallyvisible element and/or magnetically visible element. In someembodiments, functional element 133 a comprises a visualizable elementused to identify the location of optical assembly 130 on an imageproduced by an imaging device (e.g. a fluoroscope, ultrasonic imager orMRI) and the fixed location of functional element 133 a relative tooptical assembly 130 avoids registration issues, such as would beencountered if functional element 133 a was positioned on shaft 110 orother component of probe 100 whose dimensions or other relative positionto optical assembly 130 may change over time (e.g. due to expansion orcontraction due to temperature shifts). In some embodiments, functionalelement 133 a is attached to optical assembly 130 via a connectingelement, such as tube 134 described hereabove, and tube 134 or otherconnecting element (e.g. connecting element 137 described herein) isconfigured to avoid dimensional changes (e.g. is minimally affected bychanges in temperature). In some embodiments, probe 100 comprisesfixation element 136 (e.g. an adhesive such as a UV cured adhesive)positioned just distal to functional element 133 a as shown in FIG. 16,and configured to maintain the position of functional element 133 a.

Probe 100 can comprise one or more elements that cause frictionalengagement between shaft 110 and core 120 and/or simply reduce the spacebetween shaft 110 and core 120, such as one or more of elements 122 a,122 b and 122 c shown in FIG. 16, such as to reduce undesired variationsin rotational rate as described herein. In some embodiments, probe 100comprises a compression element, band 122 a, positioned about and/orwithin shaft 110 and causing a portion of the inner wall of shaft 110 tofrictionally engage core 120. Alternatively or additionally, shaft 110can comprise one or more projections 122 b (e.g. annular projections)that extend to frictionally engage core 120. Alternatively oradditionally, core 120 can comprise one or more projections 122 c, eachextending to frictionally engage shaft 110. One or more of each ofelements 122 a, 122 b and/or 122 c can be included, and each can beconfigured to create a shear force that applies a load to core 120during rotation of core 120. In some embodiments, a fluid 190 ispositioned between shaft 110 and core 120, such as a shear-thinningfluid as described herein. In these embodiments, one or more of elements122 a, 122 b and/or 122 c can comprise a space reducing elementconfigured to increase the shear-thinning of the fluid 190 as core 120is rotated (i.e. by interacting with the fluid 190 to increase theamount of thinning than that which would have occurred without thepresence of the one or more space reducing elements 122).

Referring now to FIG. 17, a side sectional view of the distal portion ofan imaging probe comprising two sealing elements is illustrated,consistent with the present inventive concepts. Probe 100 comprisesshaft 110, core 120, optical assembly 130, lens 131, reflector 132 andviewing portion 117, and those and other components of probe 100 can beof similar construction and arrangement to those described hereabove.Shaft 110 comprises lumen 112, proximal portion 111 a (not shown),distal portion 119 a and distal end 119. Probe 100 can further comprisespring tip 104. Probe 100 can comprise functional element 113, as shown,or other functional elements as described herein. Probe 100 of FIG. 17comprises two sealing elements, sealing element 116 a (e.g. an O-ringsurrounding core 120) and sealing element 116 b (e.g. an elastomericdisk). In some embodiments, a fluid 190 b is positioned within shaft 110between sealing elements 116 a and 116 b, such as is describedhereabove. Alternatively or additionally, a second fluid 190 a ispositioned within shaft 110 proximal to sealing element 116 a. In someembodiment, a third fluid 190 c (not shown), is positioned within shaft110 distal to sealing element 116 b. Fluids 190 a-c can comprise similaror dissimilar fluids, also as described hereabove.

Referring now to FIG. 18, a side sectional view of the distal portion ofan imaging probe comprising a reflecting element offset from a lens andmultiple visualizable markers is illustrated, consistent with thepresent inventive concepts. Probe 100 comprises shaft 110, core 120,optical assembly 130, lens 131 and reflector 132, and those and othercomponents of probe 100 can be of similar construction and arrangementto those described hereabove. Shaft 110 comprises lumen 112, proximalportion 111 a (not shown), distal portion 119 a and distal end 119.

In some embodiments, reflector 132 can be positioned distal to lens 131,and connected via connecting element 137, as shown in FIG. 18 anddescribed hereabove.

In some embodiments, probe 100 comprises multiple visualizable markers,such as the four functional elements 123 a shown in FIG. 18, which canbe configured to provide a “ruler function” when visualized by aseparate imaging device such as a fluoroscope, ultrasonic imager or MRI(e.g. when functional elements 123 a comprise a radiopaque marker; anultrasonically reflective marker or a magnetic marker, respectively).Functional elements 123 a can comprise one or more visualizable bands(e.g. one or more compressible bands and/or wire coils) frictionallyengaged with core 120. Alternatively or additionally, one or morefunctional elements 123 a can be positioned on, within the wall ofand/or on the inner surface of shaft 110. Functional elements 123 a canbe positioned equidistantly apart and/or at a known separation distance.In some embodiments, one or more functional elements 123 a can befurther configured as a sealing element (e.g. to provide a seal to acontained fluid such as one or more fluids 190 described herein) and/oras a rotational dampener configured to reduce undesired rotationalvelocity changes of core 120 and/or optical assembly 130.

While the preferred embodiments of the devices and methods have beendescribed in reference to the environment in which they were developed,they are merely illustrative of the principles of the present inventiveconcepts. Modification or combinations of the above-describedassemblies, other embodiments, configurations, and methods for carryingout the inventive concepts, and variations of aspects of the inventiveconcepts that are obvious to those of skill in the art are intended tobe within the scope of the claims. In addition, where this applicationhas listed the steps of a method or procedure in a specific order, itmay be possible, or even expedient in certain circumstances, to changethe order in which some steps are performed, and it is intended that theparticular steps of the method or procedure claim set forth herebelownot be construed as being order-specific unless such order specificityis expressly stated in the claim.

1. (canceled)
 2. An imaging system for a patient comprising: an imagingprobe comprising: an elongate shaft for insertion into the patient andcomprising a proximal end, a distal portion, and a lumen extendingbetween the proximal end and the distal portion; a rotatable opticalcore comprising a proximal end and a distal end, the rotatable opticalcore configured to optically and mechanically connect with a console; aprobe connector positioned on the elongate shaft proximal end andsurrounding at least a portion of the rotatable optical core; and anoptical assembly positioned in the elongate shaft distal portion andproximate the rotatable optical core distal end, the optical assemblyconfigured to direct light to tissue and collect reflected light fromthe tissue; wherein the imaging probe is constructed and arranged tocollect image data from a patient site based on the directed light andthe reflected light, wherein the optical assembly is configured to bepositioned within a first blood vessel proximate a patient site and tocollect the image data from the patient site, and wherein the patientsite comprises a location outside of the blood vessel.
 3. The imagingsystem according to claim 2, wherein the patient site comprises alocation within the intrathecal space of the spine.
 4. The imagingsystem according to claim 2, wherein the patient site comprises alocation within a second blood vessel that is outside of the first bloodvessel.
 5. The imaging system according to claim 2, wherein the patientsite comprises a location within tissue that is outside of the firstblood vessel.
 6. The imaging system according to claim 2, wherein theimaging probe is configured to access blood vessels of the brain.
 7. Theimaging system according to claim 2, wherein the optical assemblycomprises an outer diameter that is greater than an inner diameter of atleast a portion of the elongate shaft proximal to the optical assembly.8. The imaging system according to claim 2, wherein the imaging systemincludes a sensor that receives a signal related to the tissue, theconsole configured to process the signal, and a display configured todisplay a three-dimensional image from an output of the console inresponse to a retraction of the elongate shaft.
 9. The imaging systemaccording to claim 2, wherein the elongate shaft distal portioncomprises an optically transparent window, and wherein the opticalassembly is positioned within the optically transparent window.
 10. Theimaging system according to claim 9, wherein the optically transparentwindow comprises a length less than 20 mm.
 11. The imaging systemaccording to claim 2, wherein the rotatable optical core is constructedand arranged to rotate in a single direction.
 12. The imaging systemaccording to claim 2, further comprising a retraction assemblyconstructed and arranged to retract the elongate shaft and the opticalassembly while the imaging probe collects data from a target area. 13.The imaging system according to claim 2, wherein the imaging probe ofthe imaging system is configured to provide to the console quantitativeor qualitative information used to determine the size of a flow diverterof an implant to be implanted in the patient or position a flow diverterin the patient.
 14. The imaging system according to claim 13, whereinthe quantitative and/or qualitative information comprises informationrelated to a parameter selected from the group consisting of: perforatorlocation; perforator geometry; neck size; flow diverter mesh density;and combinations thereof.
 15. The imaging system according to claim 2,wherein the imaging probe of the imaging system is configured to provideimplant site information, and wherein the implant site information isused to select a particular implantable device for implantation in thepatient.
 16. The imaging system according to claim 2, wherein theimaging probe further comprises a torque shaft with a proximal end and adistal end, and wherein the torque shaft is fixedly attached to therotatable optical core such that rotation of the torque shaft rotatesthe rotatable optical core.
 17. The imaging system according to claim 2,further comprising a rotation assembly constructed and arranged torotate the rotatable optical core.
 18. The imaging system according toclaim 2, wherein the console comprises: a rotation assembly constructedand arranged to rotate the rotatable optical core; and a retractionassembly constructed and arranged to retract at least one of therotatable optical core or the elongate shaft.